Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 4:27 AM
Study NCT ID:
NCT05167734
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2021-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Practical Anemia Bundle for SusTained Blood Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007505', 'term': 'Iron-Dextran Complex'}, {'id': 'D004921', 'term': 'Erythropoietin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Warner.Matthew@mayo.edu', 'phone': '507-422-1714', 'title': 'Matthew Warner, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline through approximately 3-months after hospitalization.', 'description': 'Death was collected through 12 months post hospitalization; all other adverse events were collected from baseline through approximately 3-months post hospitalization.', 'eventGroups': [{'id': 'EG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 5, 'seriousNumAtRisk': 51, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 4, 'seriousNumAtRisk': 49, 'deathsNumAffected': 3, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Venous thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bloodstream Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venous Thromboembolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hemoglobin Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '12.6'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': '13.0'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.2', 'estimateComment': 'values greater than 0 infer higher hemoglobin in active intervention', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'MEDIAN', 'timeFrame': '1 month post-hospitalization', 'description': 'Hemoglobin is a protein that cares oxygen through the body', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected nor analyzed for four subjects in the Control (Standard of Care) Group and eight subjects in the Anemia Treatment Bundle arm'}, {'type': 'SECONDARY', 'title': 'Hemoglobin Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': 'Hospital discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '10.0'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '9.9'}]}]}, {'title': '3-months post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '13.8'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '14.6'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.0', 'ciUpperLimit': '1.1', 'estimateComment': 'adjusted mean difference', 'groupDescription': '3-months post hospitalization', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.7', 'groupDescription': 'Hospital Discharge', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge (approximately 1 month), 3 months post-hospitalization', 'description': 'Hemoglobin is a protein that cares oxygen through the body', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed for 8 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at 3-months post hospitalization.'}, {'type': 'SECONDARY', 'title': 'Phlebotomy Practice-Blood Draws', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '74'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '55'}]}]}], 'analyses': [{'pValue': '0.352', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge (approximately 1 month)', 'description': 'Number of times subjects have blood drawn', 'unitOfMeasure': 'Number of blood draws', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phlebotomy Practice-Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '195'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '54'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'threshold for significance - p\\<0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge (approximately 1 month)', 'description': 'Total volume of phlebotomy blood draws', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': 'Hospital discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '70'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '75'}]}]}, {'title': '1 month post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '75'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '80'}]}]}, {'title': '3 months post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '85'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '90'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.44', 'ciUpperLimit': '2.40', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': 'Hospital Discharge', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '0.76', 'ciUpperLimit': '4.20', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '1-month post hospitalization', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.64', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '0.51', 'ciUpperLimit': '3.00', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '3-months post hospitalization', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization', 'description': 'The EuroQol (EQ-5D) is a 5-item questionnaire that assess health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total score ranges from 0 to 100, with higher scores indicating improved health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected nor analyzed for 1 subject in the Control (Standard of Care) arm and 1 subject in the Anemia Treatment Bundle arm at hospital discharge. No data was collected or analyzed for 6 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 subjects in the control standard of care arm and 8 subjects in the anemia treatment bundle arm at 3-months post hospitalization.'}, {'type': 'SECONDARY', 'title': 'Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': 'Hosptial Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '36'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '37'}]}]}, {'title': '1 month post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '43'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '45'}]}]}, {'title': '3 months post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '46'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '48'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '0.68', 'ciUpperLimit': '4.80', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': 'Hospital discharge', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '0.87', 'ciUpperLimit': '6.80', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '1-month post hospitalization', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.52', 'ciLowerLimit': '0.88', 'ciUpperLimit': '7.20', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '3-months post hospitalization', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'MEDIAN', 'timeFrame': 'Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization', 'description': 'The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale is a 13-item questionnaire used to measure the severity of fatigue and its impact on daily activities. Each question is rated on a 4-point scale where 0 represents "very much" fatigued and 4 represents "not at all" fatigued. Total scores range from 0 to 52 with lower scores indicating greater fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected or analyzed for 1 subject in the Control Standard of Care arm and 1 subject in the Anemia Treatment Bundle arm at hospital discharge. No data was collected or analyzed for 6 subjects in the control standard of care arm and 7 subjects in the anemia treatment bundle arm at the 1-month post hospitalization. No data was collected or analyzed for 10 subject in the control standard of care arm and 8 subject in the anemia treatment bundle arm at the 3-months post hospitalization.'}, {'type': 'SECONDARY', 'title': '6 Minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': '1 month post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1080', 'groupId': 'OG000', 'lowerLimit': '790', 'upperLimit': '1250'}, {'value': '1211', 'groupId': 'OG001', 'lowerLimit': '960', 'upperLimit': '1480'}]}]}, {'title': '3 months post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1208', 'groupId': 'OG000', 'lowerLimit': '880', 'upperLimit': '1733'}, {'value': '1220', 'groupId': 'OG001', 'lowerLimit': '1040', 'upperLimit': '1683'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '218', 'ciLowerLimit': '-73', 'ciUpperLimit': '510', 'estimateComment': 'scores greater than 0 reflect greater ambulatory distance in active intervention', 'groupDescription': '1-month post hospitalization', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, and baseline ADLs'}, {'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '178', 'ciLowerLimit': '-154', 'ciUpperLimit': '510', 'groupDescription': '3-months post hospitalization', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, baseline ADLs'}], 'paramType': 'MEDIAN', 'timeFrame': '1 and 3-months post-hospitalization', 'description': 'Distance walked in 6 minutes used to assess physical function after critical illness.', 'unitOfMeasure': 'Feet', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 33 participants in the control standard of care arm and 32 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 39 participants in the control standard of care arm and 41 participants in the anemia treatment bundle arm at 3-months post hospitalization.'}, {'type': 'SECONDARY', 'title': 'Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': '1 month post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '21'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '22'}]}]}, {'title': '3 months post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '21'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '22'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.49', 'ciLowerLimit': '0.79', 'ciUpperLimit': '7.80', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '1-month post hospitalization', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.10', 'ciLowerLimit': '0.91', 'ciUpperLimit': '10.5', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '3-months post hospitalization', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'MEDIAN', 'timeFrame': '1 and 3-months post-hospitalization', 'description': 'The Montreal Cognitive Assessment (MoCA-BLIND) score assesses cognitive impairment by a 30-item questionnaire that includes tests of orientation, attention, memory, language and visual-spatial skills. Possible scores range from 0 to 30, with higher scores indicating higher cognitive function. A final total score of 26 and above is considered normal.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 11 participants in the control standard of care arm and 10 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 14 participants in the control standard of care arm and 13 participants in the in the anemia treatment bundle arm at 3-months post hospitalization.'}, {'type': 'SECONDARY', 'title': 'Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': 'Anxiety Score-1 month post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Anxiety Score-3 months post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Depression Score-1 month post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Depression Score-3 months post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.14', 'ciUpperLimit': '1.80', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '1-month post hospitalization for anxiety score', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.18', 'ciUpperLimit': '2.60', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '3-months post hospitalization for anxiety score', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.10', 'ciUpperLimit': '1.30', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '1-month post hospitalization for depression score', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.16', 'ciUpperLimit': '2.40', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '3-months post hospitalization for depression score', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'MEDIAN', 'timeFrame': '1 and 3-months post-hospitalization', 'description': "The Hospital Anxiety and Depression Scale (HADS) assesses a patient's anxiety and depression levels. Subject's answer 14 questions (7 for anxiety and 7 for depression). Each question is scored from 0-3. Total scores can range from 0 to 21 for either anxiety or depression, with higher scores indicating a presence of anxiety or depression.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 6 participants in the control standard of care arm and 7 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 participants in the control standard of care arm and 8 in the anemia treatment bundle arm at 3-months post hospitalization.'}, {'type': 'SECONDARY', 'title': 'Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': '1 month post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '11'}]}]}, {'title': '3 months post hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '0.39', 'ciUpperLimit': '5.60', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '1-month post hospitalization', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.16', 'ciLowerLimit': '1.40', 'ciUpperLimit': '59.9', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'groupDescription': '3-months post hospitalization', 'statisticalMethod': 'proportional odds', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'MEDIAN', 'timeFrame': '1 and 3-months post-hospitalization', 'description': 'The Impact of Events Scale-Revised (IES-R) is a self-reported questionnaire that measures the distress caused by traumatic events. Subjects respond to 22 questions using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total scores range from 0 to 88, with a higher score indicting the likely presence of post-traumatic stress disorder (PTSD).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 6 participants in the control standard of care arm and 7 participants in the anemia treatment bundle arm at 1-month post hospitalization. No data was collected or analyzed for 10 participants in the control standard of care arm and 8 in the anemia treatment bundle arm at 3-months post hospitalization.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Allogeneic Red Blood Cell Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '0.02', 'ciUpperLimit': '1.40', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-months post-hospitalization', 'description': 'Number (percentage) of patients transfused with allogeneic red blood cells', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 1 participant in the anemia treatment bundle arm.'}, {'type': 'SECONDARY', 'title': 'Number of Transfused Units of Allogeneic Red Blood Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months post hospitalization', 'description': 'Number of transfused units from hospital discharge through 3-months post-hospitalization', 'unitOfMeasure': 'Transfused units', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 1 participant in the anemia treatment bundle arm.'}, {'type': 'SECONDARY', 'title': 'Unplanned Hospital Readmissions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': '3 months post hospitalization', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '12 months post hospitalization', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.30', 'ciUpperLimit': '1.80', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention', 'groupDescription': '3-months post hospitalization', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months and 12-months post-hospitalization', 'description': 'Number of subjects to experience an unplanned hospital readmission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 1 participant in the anemia treatment bundle arm at 3-months post hospitalization. No data was collected or analyzed for 1 participant in the anemia treatment bundle arm at 12-months post hospitalization.'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': '3 months post hospitalization', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '12 months post hospitalization', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '0.19', 'ciUpperLimit': '24.0', 'estimateComment': 'Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention', 'groupDescription': '3-months post hospitalization', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months and 12-months post-hospitalization', 'description': 'Mortality from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events Post-enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': 'Venous Thromboembolism', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bloodstream Infection', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Stroke', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hospital discharge (approximately 1 month), 3-months post-hospitalization', 'description': 'Venous thromboembolism, bloodstream infection, myocardial infarction, stroke', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Accelerometry-measured Number of Steps Taken Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': '1 month post hospitalization', 'categories': [{'measurements': [{'value': '6481', 'groupId': 'OG000', 'lowerLimit': '2690', 'upperLimit': '14772'}, {'value': '6017', 'groupId': 'OG001', 'lowerLimit': '3046', 'upperLimit': '9010'}]}]}, {'title': '3 month post hospitalization', 'categories': [{'measurements': [{'value': '8281', 'groupId': 'OG000', 'lowerLimit': '2535', 'upperLimit': '13816'}, {'value': '6874', 'groupId': 'OG001', 'lowerLimit': '2275', 'upperLimit': '11972'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 and 3-months post-hospitalization', 'description': 'Home-based activity monitor daily step counts (optional, exploratory study component)', 'unitOfMeasure': 'Number of steps per day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 33 participants in the control standard of care arm and 27 participants in the anemia treatment bundle arm.'}, {'type': 'SECONDARY', 'title': 'Accelerometry-measured Daily Maximum Step Cadence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'OG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'classes': [{'title': '1 month post hospitalization', 'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '102.5'}, {'value': '64.4', 'groupId': 'OG001', 'lowerLimit': '29.8', 'upperLimit': '109.5'}]}]}, {'title': '3 months post hospitalization', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '106.3'}, {'value': '61.4', 'groupId': 'OG001', 'lowerLimit': '29.5', 'upperLimit': '110.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 month and 3 month post hospitalization', 'description': 'Actigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint)', 'unitOfMeasure': 'Steps per Minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected or analyzed for 33 participants in the control standard of care arm and 27 participants in the anemia treatment bundle arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'FG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control (Standard of Care) Group', 'description': 'Subjects received standard clinical care for the treatment of anemia while in the ICU.'}, {'id': 'BG001', 'title': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).\n\nIron Dextran: 1000 mg IV\n\nErythropoietin (EPO): 40,000 units subcutaneous'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-11', 'size': 1834353, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-04T16:36', 'hasProtocol': True}, {'date': '2023-09-27', 'size': 494260, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-14T09:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2021-11-30', 'resultsFirstSubmitDate': '2025-02-11', 'studyFirstSubmitQcDate': '2021-12-09', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-19', 'studyFirstPostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemoglobin Concentrations', 'timeFrame': '1 month post-hospitalization', 'description': 'Hemoglobin is a protein that cares oxygen through the body'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin Concentrations', 'timeFrame': 'Hospital discharge (approximately 1 month), 3 months post-hospitalization', 'description': 'Hemoglobin is a protein that cares oxygen through the body'}, {'measure': 'Phlebotomy Practice-Blood Draws', 'timeFrame': 'Hospital discharge (approximately 1 month)', 'description': 'Number of times subjects have blood drawn'}, {'measure': 'Phlebotomy Practice-Volume', 'timeFrame': 'Hospital discharge (approximately 1 month)', 'description': 'Total volume of phlebotomy blood draws'}, {'measure': 'Patient-Reported Quality of Life Measured by EuroQol (EQ-5D)', 'timeFrame': 'Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization', 'description': 'The EuroQol (EQ-5D) is a 5-item questionnaire that assess health-related quality of life over five different dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total score ranges from 0 to 100, with higher scores indicating improved health.'}, {'measure': 'Anemia-related Fatigue Measured by Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale', 'timeFrame': 'Hospital discharge (approximately 1 month), 1 month post-hospitalization, 3 months post-hospitalization', 'description': 'The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale is a 13-item questionnaire used to measure the severity of fatigue and its impact on daily activities. Each question is rated on a 4-point scale where 0 represents "very much" fatigued and 4 represents "not at all" fatigued. Total scores range from 0 to 52 with lower scores indicating greater fatigue.'}, {'measure': '6 Minute Walk Distance', 'timeFrame': '1 and 3-months post-hospitalization', 'description': 'Distance walked in 6 minutes used to assess physical function after critical illness.'}, {'measure': 'Cognitive Function After Critical Illness Assessed Using Montreal Cognitive Assessment (MoCA-BLIND)', 'timeFrame': '1 and 3-months post-hospitalization', 'description': 'The Montreal Cognitive Assessment (MoCA-BLIND) score assesses cognitive impairment by a 30-item questionnaire that includes tests of orientation, attention, memory, language and visual-spatial skills. Possible scores range from 0 to 30, with higher scores indicating higher cognitive function. A final total score of 26 and above is considered normal.'}, {'measure': 'Mental Health - Anxiety and Depression Measured Using the Hosptial Anxiety and Depression Scale (HADS)', 'timeFrame': '1 and 3-months post-hospitalization', 'description': "The Hospital Anxiety and Depression Scale (HADS) assesses a patient's anxiety and depression levels. Subject's answer 14 questions (7 for anxiety and 7 for depression). Each question is scored from 0-3. Total scores can range from 0 to 21 for either anxiety or depression, with higher scores indicating a presence of anxiety or depression."}, {'measure': 'Mental Health - Post-Traumatic Distress Using Impact of Events Scale-Revised (IES-R)', 'timeFrame': '1 and 3-months post-hospitalization', 'description': 'The Impact of Events Scale-Revised (IES-R) is a self-reported questionnaire that measures the distress caused by traumatic events. Subjects respond to 22 questions using a 5-point scale ranging from 0 (not at all) to 4 (extremely). Total scores range from 0 to 88, with a higher score indicting the likely presence of post-traumatic stress disorder (PTSD).'}, {'measure': 'Number of Participants With Allogeneic Red Blood Cell Transfusions', 'timeFrame': '3-months post-hospitalization', 'description': 'Number (percentage) of patients transfused with allogeneic red blood cells'}, {'measure': 'Number of Transfused Units of Allogeneic Red Blood Cells', 'timeFrame': '3 months post hospitalization', 'description': 'Number of transfused units from hospital discharge through 3-months post-hospitalization'}, {'measure': 'Unplanned Hospital Readmissions', 'timeFrame': '3 months and 12-months post-hospitalization', 'description': 'Number of subjects to experience an unplanned hospital readmission'}, {'measure': 'Mortality', 'timeFrame': '3 months and 12-months post-hospitalization', 'description': 'Mortality from any cause'}, {'measure': 'Adverse Events Post-enrollment', 'timeFrame': 'Hospital discharge (approximately 1 month), 3-months post-hospitalization', 'description': 'Venous thromboembolism, bloodstream infection, myocardial infarction, stroke'}, {'measure': 'Accelerometry-measured Number of Steps Taken Per Day', 'timeFrame': '1 and 3-months post-hospitalization', 'description': 'Home-based activity monitor daily step counts (optional, exploratory study component)'}, {'measure': 'Accelerometry-measured Daily Maximum Step Cadence', 'timeFrame': '1 month and 3 month post hospitalization', 'description': 'Actigraphy evaluated daily Max Step Cadence - i.e., steps per minute (optional, exploratory study endpoint)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '40152861', 'type': 'DERIVED', 'citation': 'Warner MA, Johnson ML, Hanson AC, Fortune E, Flaby GW, Schulte PJ, Hazelton VM, Go RS, Beam WB, Charnin JE, Anderson BK, Karon B, Cheville AL, Gajic O, Kor DJ. Practical Anemia Bundle and Hemoglobin Recovery in Critical Illness: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e252353. doi: 10.1001/jamanetworkopen.2025.2353.'}, {'pmid': '36460332', 'type': 'DERIVED', 'citation': 'Warner MA, Go RS, Schulte PJ, Beam WB, Charnin JE, Meade L, Droege KA, Anderson BK, Johnson ML, Karon B, Cheville A, Gajic O, Kor DJ. Practical Anemia Bundle for Sustained Blood Recovery (PABST-BR) in critical illness: a protocol for a randomised controlled trial. BMJ Open. 2022 Dec 2;12(12):e064017. doi: 10.1136/bmjopen-2022-064017.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a multi-faceted anemia treatment plan to reduce the severity of anemia and to promote hemoglobin and functional recovery in adults who have been in the intensive care unit (ICU).', 'detailedDescription': 'Anemia is common during critical illness and is associated with impaired outcomes during and after hospitalization. The goal of this investigation is to test a multi-faceted anemia prevention and targeted treatment bundle to attenuate anemia development and promote functional recovery in the setting of critical illness. Specifically, this will be a pragmatic phase II clinical trial of a multi-faceted anemia prevention and treatment bundle with 3 aspects (optimized phlebotomy practice, clinical decision support, targeted pharmacologic anemia treatment) assessing the impact of the intervention on hemoglobin concentrations (primary aim), transfusion utilization, and functional outcomes through 3 months after hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated informed consent form (may be completed by legal proxies for those patients unable to provide consent, i.e. sedation/intubation)\n* Stated willingness to comply with all study procedures and availability for the duration of the study, including follow-up assessments\n* Current ICU admission at Mayo Clinic Rochester with anticipated ICU duration \\>48 hours after enrollment\n* Current ICU duration \\< 7 days\n* Patients embedded in the local or regional Mayo Clinic Health System to facilitate post-hospitalization outcome assessment\n* Moderate-to-severe anemia (i.e. hemoglobin concentration \\< 10 g/dL) at the time of enrollment, with the hemoglobin concentration assessed no more than 24 hours prior to enrollment. If RBC transfusion has been administered between the qualifying hemoglobin assessment and enrollment, a repeat hemoglobin will be required prior to enrollment to ensure that it remains \\< 10 g/dL.\n\nExclusion Criteria:\n\n* Recent or current IV iron or erythropoiesis stimulating agent (ESA) use (i.e. darbepoetin, Aranesp, erythropoietin, Epogen, Procrit, Retacrit) within 30 days of enrollment\n* Severe anemia prior to hospitalization (i.e. hemoglobin \\<9 g/dL within 90 days of admission)\n* Known allergic reactions to iron or EPO\n* Inability to complete outcome assessments (i.e. not expected to survive hospitalization, unable to make follow-up appointments, non-ambulatory, dementia or other severe cognitive impairment, visual impairment i.e. blind or legally blind)\n* Pregnancy or breastfeeding at time of enrollment\n* Inability to receive pharmacologic venous thromboembolic prophylaxis except in patients with recent surgical or gastrointestinal bleeding\n* Active or suspected thrombosis (i.e. deep venous thrombosis, pulmonary embolism, acute arterial thrombus within 3 months)\n* Uncontrolled sepsis (i.e. \\<48 hours of appropriate antimicrobial therapy and/or lack of definitive source control)\n* Having received ≥10 units of allogeneic RBCs in the 48 hours before enrollment\n* Acute coronary syndrome or ischemic stroke within 3 months\n* Weight less than 40 kg\n* Concerns with study enrollment expressed by the clinical team\n* Mechanical circulatory support devices'}, 'identificationModule': {'nctId': 'NCT05167734', 'acronym': 'PABST-BR', 'briefTitle': 'Practical Anemia Bundle for SusTained Blood Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Practical Anemia Bundle for SusTained Blood Recovery (PABST-BR) Clinical Trial', 'orgStudyIdInfo': {'id': '21-006511'}, 'secondaryIdInfos': [{'id': 'K23HL153310-01', 'link': 'https://reporter.nih.gov/quickSearch/K23HL153310-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control (Standard of Care) Group', 'description': 'Subjects will receive standard clinical care for the treatment of anemia while in the ICU.'}, {'type': 'EXPERIMENTAL', 'label': 'Anemia Treatment Bundle', 'description': 'The intervention arm is multi-faceted with 3 primary components: 1) Optimized phlebotomy, defined by minimal volume draws and closed-loop blood sampling, all performed by a dedicated phlebotomy team independent from the treatment team; 2) Decision support aids, including visual and electronic alerts reminding the care team to minimize non-essential laboratory testing and mitigate patient-specific bleeding risk; and 3) Pharmacologic anemia treatment with a single dose of IV iron and/or subcutaneous erythropoietin (given immediately following enrollment) targeted to 2 broad groups: 1) anemias responsive to iron supplementation alone (i.e. acute blood loss, iron deficiency) and 2) anemias requiring erythropoietic stimulation (e.g. anemia of inflammation, anemia of renal disease).', 'interventionNames': ['Drug: Iron Dextran', 'Drug: Erythropoietin (EPO)']}], 'interventions': [{'name': 'Iron Dextran', 'type': 'DRUG', 'description': '1000 mg IV', 'armGroupLabels': ['Anemia Treatment Bundle']}, {'name': 'Erythropoietin (EPO)', 'type': 'DRUG', 'otherNames': ['EPO'], 'description': '40,000 units subcutaneous', 'armGroupLabels': ['Anemia Treatment Bundle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Matthew Warner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'timeFrame': 'We commit to providing data immediately upon acceptance of the data for scientific publication or within one year of completion of the award period (whichever comes first).', 'ipdSharing': 'YES', 'description': 'Study data will be shared through the NHLBI Data Repository, which is managed by thenBiologic Specimen and Data Repository Information Coordinating Center (BioLINCC). In addition to study data (e.g. information recorded for each study participant including demographics, clinical characteristics, laboratory assessments, and outcomes / follow-up assessments), study documentation information will also be provided in order to facilitate secondary use of data by investigators not familiar with the original data set. This includes a summary documentation file, manuals of procedures, detailed statistical code, and data dictionary information, among other important documentation. The timing and manner of research data uploading to the Data Repository will be in full compliance with NHLBI guidelines.', 'accessCriteria': 'All published scientific manuscripts will contain information regarding how to request and access study data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matthew A. Warner', 'investigatorAffiliation': 'Mayo Clinic'}}}}