Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-20 @ 6:23 PM
Study NCT ID:
NCT02802592
Status:
TERMINATED
Last Update Posted:
2019-02-26
First Post:
2016-06-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068817', 'term': 'Epoetin Alfa'}, {'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '301-896-3100', 'title': 'Dr. Kenneth Horvath', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': '1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm\n\nOR\n\n250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mediastinal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Complete Heart Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Acute Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ankle Edema (Bilateral)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}], 'seriousEvents': [{'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epogen', 'description': '1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr\n\nEpogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': '250 ml normal saline infused over 1 hr\n\nNormal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}], 'timeFrame': 'Start of surgery to 96 hours post op', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Length of Stay (# of Total Days Hospitalized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epogen', 'description': '1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr\n\nEpogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': '250 ml normal saline infused over 1 hr\n\nNormal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}], 'timeFrame': 'up to one year from date of surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Overall Hospitalization Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epogen', 'description': '1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr\n\nEpogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': '250 ml normal saline infused over 1 hr\n\nNormal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}], 'timeFrame': 'up to one year from date of surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Epogen', 'description': '1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr\n\nEpogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}, {'id': 'OG001', 'title': 'Normal Saline', 'description': '250 ml normal saline infused over 1 hr\n\nNormal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}], 'timeFrame': 'assessed at 1-week, 1-month, and 3-months from date of surgery', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': '1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm\n\nOR\n\n250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Study terminated due to loss of funding', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'This study was terminated due to loss of funding and those participants enrolled were not un-blinded to the study team members.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': '1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr Epogen: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm\n\nOR\n\n250 ml normal saline infused over 1 hr Normal Saline: 1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This study was terminated due to loss of funding and those participants enrolled were not un-blinded to the study team members.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Loss of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-04', 'studyFirstSubmitDate': '2016-06-03', 'resultsFirstSubmitDate': '2017-08-17', 'studyFirstSubmitQcDate': '2016-06-13', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-17', 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period', 'timeFrame': 'Start of surgery to 96 hours post op'}], 'secondaryOutcomes': [{'measure': 'Length of Stay (# of Total Days Hospitalized)', 'timeFrame': 'up to one year from date of surgery'}, {'measure': 'Overall Hospitalization Cost', 'timeFrame': 'up to one year from date of surgery'}, {'measure': 'Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey', 'timeFrame': 'assessed at 1-week, 1-month, and 3-months from date of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery-CABG', 'Cardiac Valve Replacement']}, 'descriptionModule': {'briefSummary': 'EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)', 'detailedDescription': 'The investigator proposes a study investigating the use of restrictive transfusion triggers and administration of single preoperative high dose shot of epoetin alfa (rhEPO) in a young (age \\< 65 years of age) population undergoing cardiac surgery. The investigator believes that participants can tolerate a lower Hemoglobin (Hgb). Therefore, the control group will benefit from a restrictive transfusion trigger and experimental group will benefit from EPO providing a synergistic stimulus for erythropoiesis. This proposed study has potential to reduce overall transfusion utilization in cardiac surgery and improve standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be male or female and 18 years of age or older, but less than 65 years of age\n* Be willing to performed written informed consent prior to study initiation\n* Be willing and able to comply with the protocol for study duration\n* Be scheduled to undergo elective cardiac surgery requiring CPB and including: coronary artery bypass graft (CABG), aortic, mitral, or tricuspid valve replacement or repair, replacement of more than one cardiac valve, or CABG with combined cardiac valve replacement or repair.\n\nExclusion Criteria:\n\n* Over the age of 64 years\n* Patients who receive allogeneic transfusion 60 days prior to surgery\n* Hgb \\> 15g/dl\n* Patients who are pregnant or currently lactating\n* Women of childbearing potential (e.g. those not surgically sterilized or not post-menopausal) must use 2 methods of contraception including at least one barrier method.\n* End-stage renal disease requiring renal replacement therapy or dialysis\n* Hepatic dysfunction (defined as total bilirubin value \\> 1.5 mg/dl)\n* Off-pump (no CPB) cardiac surgery\n* Emergency surgical procedure\n* Inability to receive blood products\n* Endocarditis as defined my Modified Duke Criteria\n* Any congenital coagulation disorder\n* Chronic anemia (defined as preoperative Hgb concentration \\< 10 g/dl)\n* Low platelet count (defined as preoperative platelet count less than 150 x 103/μl)\n* Not a surgical candidate due to high risk of morbidity or mortality\n* Surgery for aneurysm repair, dissection, or other thoracic aortic procedure\n* Congenital heart surgery\n* Cardiogenic shock or hemodynamic instability within 24 hours prior to surgery, as defined by systolic blood pressure \\< 80 mmHg and heart rate \\> 120 beats per minute\n* Known malignancy within the past 5 years\n* Life expectancy \\< 12 months\n* Current active infection requiring antibiotic treatment\n* Inability to comply with study protocol\n* Contraindication to Epogen\n* Hypersensitivity to epoetin or any component of the formulation\n* Pure red cell aplasia (due to epoetin or other epoetin protein drugs)\n* Contraindication to Ferrous Sulfate\n* Hypersensitivity to iron salts or any component of the formulation\n* Hemochromatosis\n* Hemolytic anemia\n* In the opinion of the Principle Investigator (PI) any specific disease process or confounding variables that may inappropriately alter the outcome of the study'}, 'identificationModule': {'nctId': 'NCT02802592', 'acronym': 'EPORT', 'briefTitle': 'EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'EPOgen and Restrictive Transfusions in Patients Undergoing Cardiac Surgery (EPORT)', 'orgStudyIdInfo': {'id': 'IRB00050961'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epogen', 'description': '1000 IU/kg Epogen in 250 ml of normal saline infused over 1 hr', 'interventionNames': ['Drug: Epogen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'description': '250 ml normal saline infused over 1 hr', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Epogen', 'type': 'DRUG', 'otherNames': ['EPOETIN', 'Procrit'], 'description': '1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm', 'armGroupLabels': ['Epogen']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': '1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Suburban Hospital', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Keith A. Horvath, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Community Physicians'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}