Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-26 @ 8:41 AM
Study NCT ID:
NCT02094118
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2014-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065227', 'term': 'Transfusion Reaction'}, {'id': 'D000073617', 'term': 'Transfusion-Related Acute Lung Injury'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kor.daryl@mayo.edu', 'phone': '507-255-6051', 'title': 'Dr. Daryl Kor', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From randomization to hospital discharge, death, or day 28 (whichever occurs first).', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells transfusion that were administered in the standard of care', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 0, 'seriousNumAtRisk': 85, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells transfusion that were washed at the point-of-care.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'deathsNumAffected': 3, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'hypoxemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Profound Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells transfusion that were administered in the standard of care'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells transfusion that were washed at the point-of-care.'}], 'classes': [{'title': 'IL-6', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '197'}, {'value': '105', 'groupId': 'OG001', 'lowerLimit': '70', 'upperLimit': '191'}]}]}, {'title': 'IL-8', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '23'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '26'}]}]}, {'title': 'vWF', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '137'}, {'value': '111', 'groupId': 'OG001', 'lowerLimit': '74', 'upperLimit': '142'}]}]}, {'title': 'RAGE', 'categories': [{'measurements': [{'value': '3262', 'groupId': 'OG000', 'lowerLimit': '2326', 'upperLimit': '6899'}, {'value': '4516', 'groupId': 'OG001', 'lowerLimit': '2354', 'upperLimit': '5907'}]}]}, {'title': 'SP_D', 'categories': [{'measurements': [{'value': '7238', 'groupId': 'OG000', 'lowerLimit': '4962', 'upperLimit': '11900'}, {'value': '7061', 'groupId': 'OG001', 'lowerLimit': '4470', 'upperLimit': '13318'}]}]}, {'title': 'PAI_1', 'categories': [{'measurements': [{'value': '73418', 'groupId': 'OG000', 'lowerLimit': '38900', 'upperLimit': '196491'}, {'value': '53829', 'groupId': 'OG001', 'lowerLimit': '21044', 'upperLimit': '151009'}]}]}, {'title': 'ICAM_1', 'categories': [{'measurements': [{'value': '404914', 'groupId': 'OG000', 'lowerLimit': '313796', 'upperLimit': '513060'}, {'value': '404129', 'groupId': 'OG001', 'lowerLimit': '309411', 'upperLimit': '538055'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '18 hours after the initiation of the first red blood cell transfusion.', 'description': 'This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.', 'unitOfMeasure': 'units on a scale (pg/ml)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients undergoing cardiac surgery who were predicted to be at high risk for requiring red blood cell transfusion.'}, {'type': 'PRIMARY', 'title': 'Number of "Off-protocol" Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells transfusion that were administered in the standard of care'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells transfusion that were washed at the point-of-care.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery. Approximately 1 day.', 'description': 'The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion.', 'unitOfMeasure': 'transfusions', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Recipient Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.\n\nStandard of care red blood cell transfusion.'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.\n\nPoint-of-care washed red blood cell transfusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.6'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '3.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre to 6 hours post transfusion', 'description': 'Change in Hemoglobin from pre-transfusion to post-transfusion', 'unitOfMeasure': 'units on a scale (g/dl)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Recipient Cell Free Hemoglobin(CFH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '52'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '58.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre transfusion until study day 5 or hospital discharge, approximately 5 days', 'description': 'Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion', 'unitOfMeasure': 'units on a scale (mg/dl)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Haptoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.5', 'groupId': 'OG000', 'lowerLimit': '-95', 'upperLimit': '-16.5'}, {'value': '-54', 'groupId': 'OG001', 'lowerLimit': '-103', 'upperLimit': '-7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre transfusion to study day 5 or hospital discharge, approximately 5 days', 'description': 'Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion', 'unitOfMeasure': 'units on a scale (mg/dl)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '23.5'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '20.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to hospital day 28, or discharge, whichever comes first', 'description': 'Number of hours subject received mechanical ventilation.', 'unitOfMeasure': 'units on a scale (hours)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Oxygen Supplementation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.7', 'groupId': 'OG000', 'lowerLimit': '45.5', 'upperLimit': '142.7'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '39.9', 'upperLimit': '180.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to day 28, or hospital discharge, whichever comes first', 'description': 'Number of hours subjects received supplemental oxygen.', 'unitOfMeasure': 'units on a scale (hours)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sequential Organ Failure Assessment (SOFA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '14'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through postoperative day 5.', 'description': 'Worst SOFA score between Day 1 and Day 5. SOFA scores range from 0-24 with 0 meaning no organ dysfunction and 24 means severe dysfunction of all organ systems evaluated. Each of 6 organ systems are scored on a 0-4 scale with the cumulative score being the total SOFA score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '17'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to day 28', 'description': 'Number of days subject remained in the hospital following their surgical procedure. If the number of days the subject remained in the hospital exceeded 28, a value of 28 is assigned.', 'unitOfMeasure': 'units on a scale (days)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Post Transfusion Respiratory Complications.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.'}, {'id': 'OG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.'}], 'classes': [{'title': 'TACO', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'TRALI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to day 28', 'description': 'Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered as standard of care.\n\nStandard of care red blood cell transfusion.'}, {'id': 'FG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.\n\nPoint-of-care washed red blood cell transfusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care Red Blood Cell Transfusion', 'description': 'Red blood cells that are administered in the normal fashion.\n\nStandard of care red blood cell transfusion.'}, {'id': 'BG001', 'title': 'Point-of-Care Washed Red Blood Cell Transfusion', 'description': 'Red blood cells that are washed at the point-of-care.\n\nPoint-of-care washed red blood cell transfusion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', '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': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '130', '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': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-17', 'size': 1228538, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-03T15:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2020-04-21', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2014-03-19', 'dispFirstSubmitQcDate': '2020-04-21', 'resultsFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2014-03-20', 'dispFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-11', 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload.', 'timeFrame': '18 hours after the initiation of the first red blood cell transfusion.', 'description': 'This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury.'}, {'measure': 'Number of "Off-protocol" Transfusions', 'timeFrame': 'Day of surgery. Approximately 1 day.', 'description': 'The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion.'}, {'measure': 'Change in Recipient Hemoglobin', 'timeFrame': 'Pre to 6 hours post transfusion', 'description': 'Change in Hemoglobin from pre-transfusion to post-transfusion'}, {'measure': 'Change in Recipient Cell Free Hemoglobin(CFH)', 'timeFrame': 'Pre transfusion until study day 5 or hospital discharge, approximately 5 days', 'description': 'Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion'}, {'measure': 'Change in Haptoglobin', 'timeFrame': 'Pre transfusion to study day 5 or hospital discharge, approximately 5 days', 'description': 'Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion'}], 'secondaryOutcomes': [{'measure': 'Duration of Mechanical Ventilation', 'timeFrame': 'Up to hospital day 28, or discharge, whichever comes first', 'description': 'Number of hours subject received mechanical ventilation.'}, {'measure': 'Duration of Oxygen Supplementation', 'timeFrame': 'Up to day 28, or hospital discharge, whichever comes first', 'description': 'Number of hours subjects received supplemental oxygen.'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) Score', 'timeFrame': 'Through postoperative day 5.', 'description': 'Worst SOFA score between Day 1 and Day 5. SOFA scores range from 0-24 with 0 meaning no organ dysfunction and 24 means severe dysfunction of all organ systems evaluated. Each of 6 organ systems are scored on a 0-4 scale with the cumulative score being the total SOFA score.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Up to day 28', 'description': 'Number of days subject remained in the hospital following their surgical procedure. If the number of days the subject remained in the hospital exceeded 28, a value of 28 is assigned.'}, {'measure': 'Post Transfusion Respiratory Complications.', 'timeFrame': 'Up to day 28', 'description': 'Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transfusion', 'RBC', 'cardiac', 'surgery', 'transfusion related acute lung injury (TRALI)', 'transfusion associated circulatory overload (TACO)'], 'conditions': ['Blood Transfusion Complications']}, 'referencesModule': {'references': [{'pmid': '28821525', 'type': 'DERIVED', 'citation': 'Warner MA, Welsby IJ, Norris PJ, Silliman CC, Armour S, Wittwer ED, Santrach PJ, Meade LA, Liedl LM, Nieuwenkamp CM, Douthit B, van Buskirk CM, Schulte PJ, Carter RE, Kor DJ. Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery. BMJ Open. 2017 Aug 18;7(8):e016398. doi: 10.1136/bmjopen-2017-016398.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal to or greater than 18 years of age.\n* Scheduled to have cardiac bypass surgery at Mayo Clinic in Rochester, Minnesota or Duke University Medical Center in Durham, North Carolina\n* At risk for needing at least 4 units of blood during/after surgery\n\nExclusion Criteria:\n\n* Emergency surgery\n* Immunoglobulin A (IgA) deficiency\n* History of severe recurrent transfusion reactions\n* Refusal to receive allogeneic blood products\n* Refusal to provide informed consent\n* Prevalent lung injury prior to randomization\n* Prevalent congestive heart failure prior to randomization\n* Expected hospital stay \\< 48 hours\n* Not anticipated to survive \\> 48 hours\n* Previously enrolled in this trial\n* No plan for placement of a pulmonary artery catheter\n* Use of home oxygen therapy\n* Complex RBC antibody profiles\n* Need for the use of irradiated RBCs'}, 'identificationModule': {'nctId': 'NCT02094118', 'briefTitle': 'Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Point-of-Care RBC Washing to Prevent Transfusion-Related Pulmonary Complications', 'orgStudyIdInfo': {'id': '13-005965'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care red blood cell transfusion', 'description': 'Red blood cells that are administered in the normal fashion.', 'interventionNames': ['Biological: Standard of care red blood cell transfusion.']}, {'type': 'EXPERIMENTAL', 'label': 'Point-of-Care washed red blood cell transfusion', 'description': 'Red blood cells that are washed at the point-of-care.', 'interventionNames': ['Biological: Point-of-care washed red blood cell transfusion.']}], 'interventions': [{'name': 'Point-of-care washed red blood cell transfusion.', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Point-of-Care washed red blood cell transfusion']}, {'name': 'Standard of care red blood cell transfusion.', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Standard of care red blood cell transfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Daryl Kor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Vitalant Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthsiology', 'investigatorFullName': 'Daryl J. Kor, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}