Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 10:49 PM
Study NCT ID:
NCT01178333
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2010-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sassmann@neriscience.com', 'phone': '617-972-3048', 'title': 'Dr. Susan Assmann, Principal Research Scientist', 'organization': 'New England Research Institutes'}, 'certainAgreement': {'otherDetails': 'All publications and presentations resulting from studies from the TMH Network must be approved by the Publications and Presentations Committee before submission. The Sponsor (NERI) and funding agency (NHLBI) both are represented on the P\\&P Committee along with Network Investigators. Members of the P\\&P Committee can recommend changes to publications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'HIT-RADIO was a retrospective study so there were no adverse events collected/reported.', 'eventGroups': [{'id': 'EG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '34.5', 'spread': '2.64', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '0.90', 'ciUpperLimit': '4.36', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.45', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.65', 'ciUpperLimit': '2.66', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'comment': 'Due to lack of events, the upper interval of the median survival time could not be estimated.', 'groupId': 'OG000', 'lowerLimit': '23.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to lack of events, the median survival time and 95% confidence interval could not be estimated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to lack of events, the median survival time and the upper interval could not be estimated.', 'groupId': 'OG002', 'lowerLimit': '29.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The median survival time is reported by each group for the time to death.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of Limb Amputation or Limb Gangrene', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.76', 'ciLowerLimit': '0.55', 'ciUpperLimit': '40.87', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.78', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.16', 'ciUpperLimit': '11.25', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'Due to the small number of events, the median or mean survival time could not be defined. Therefore, the number of subjects with limb amputation or limb gangrene was reported in "Outcome Measure Data Table".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of Radiographically Confirmed Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '5.74', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.38', 'ciLowerLimit': '0.98', 'ciUpperLimit': '5.79', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.11', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.91', 'ciLowerLimit': '0.87', 'ciUpperLimit': '4.21', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. However, the median survival times could not be defined for all three groups, so the mean time was reported in "Outcome Measure Data Table".', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '17.2', 'spread': '0.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.80', 'ciLowerLimit': '1.50', 'ciUpperLimit': '5.22', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.02', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '1.12', 'ciUpperLimit': '3.45', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Occurrence of Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '28.0'}, {'value': '36.0', 'comment': 'Due to lack of events, the upper interval of median survival time could not be estimated.', 'groupId': 'OG001', 'lowerLimit': '31.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to lack of events, the median survival time and the upper interval could not be estimated.', 'groupId': 'OG002', 'lowerLimit': '16.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The median survival time is reported by each group for the time to occurrence of major bleeding.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn', 'description': 'Proportion of subjects who, at the time the positive heparin PF-4 antibody test was drawn, were in each of the following categories:\n\n* Group 1: Those with thrombosis and or without thrombocytopenia (HIT-T): 16% of 442 subjects.\n* Group 2: Those with thrombocytopenia but not thrombosis (Isolated HIT): 64% of 442 subjects.\n* Group 3: Those with neither thrombocytopenia nor thrombosis (Neither HIT-T nor Isolated HIT): 20% of 442 subjects.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Type of Heparin Exposure - Unfractionated Heparin (UFH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'title': 'Number of subjects with heparin exposure:UFH', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}, {'title': 'Number of subjects without heparin exposure:UFH', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is to compare three groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn', 'description': 'Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). UFH has been used for the prevention and treatment of thrombosis for several decades.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'title': 'Number of subjects with heparin exposure:LMWH', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Number of subjects without heparin exposure:LMWH', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is to compare three groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn', 'description': 'Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). LMWHs are derived from UFH by depolymerization. Each LMWH product has a specific molecular weight distribution that determines its anticoagulant activity and duration of action.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'title': 'Optical density Results less than 1.0', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Optical density Results greater or equal to 1.0', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is to compare three groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': "Heparin PF-4 (platelet factor 4) optical density (OD) test results were the dichotomous outcome (\\<1.0 vs. \\>=1.0). Clinical diagnosis was three groups (HIT-T, Isolated HIT and No HIT). The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There was one missing data for optical density test results in Isolated HIT group. Therefore, 283 subjects were used for Isolated HIT group.'}, {'type': 'SECONDARY', 'title': 'Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OD Result < 1.0', 'description': 'Heparin-PF4 OD Test Results \\< 1.0'}, {'id': 'OG001', 'title': 'OD Result >= 1.0', 'description': 'Heparin-PF4 OD Test Results \\>= 1.0'}], 'classes': [{'categories': [{'measurements': [{'value': '87.7', 'spread': '92.4', 'groupId': 'OG000'}, {'value': '83.1', 'spread': '76.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': "Heparin PF-4 optical density (OD) test results were the dichotomous outcome (\\<1.0 vs. \\>=1.0). Nadir Platelet Count (x10\\^9 / L) was used for the degree of thrombocytopenia. The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.", 'unitOfMeasure': 'X10^9 / L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OD Result < 1.0', 'description': 'Heparin-PF4 OD Test Results \\< 1.0'}, {'id': 'OG001', 'title': 'OD Result >= 1.0', 'description': 'Heparin-PF4 OD Test Results \\>= 1.0'}], 'classes': [{'title': 'Composite endpoint', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'No composite endpoint', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'Heparin PF-4 OD test results were the dichotomous outcome (\\<1.0 vs. \\>=1.0). Primary endpoint was the composite endpoint of death, limb amputation/gangrene, or new thrombosis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Treatment (Non-heparin Anticoagulant) Used in Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'title': 'Number of subjects with treatment in hospital', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Number of subjects without treatment in hospital', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is to compare three groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'Types of treatment (direct thrombin inhibitor, fondaparinux, warfarin, no treatment) provided to subjects in hospital', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '31.4', 'spread': '2.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.48', 'ciLowerLimit': '1.35', 'ciUpperLimit': '4.55', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.07', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.66', 'ciLowerLimit': '0.96', 'ciUpperLimit': '2.85', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.', 'description': 'The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'comment': 'Due to lack of events, the upper interval of the median survival time could not be estimated.', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': 'NA'}, {'value': '33.0', 'comment': 'Due to lack of events, the upper interval of the median survival time could not be estimated.', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to lack of events, the median survival time and the upper interval could not be estimated.', 'groupId': 'OG002', 'lowerLimit': '29.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.', 'description': 'The median survival time is reported by each group for the time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'title': 'Number of subjects with treatment at discharge', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Number of subjects with no treatment at discharge', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value is to compare three groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'OG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'OG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.16', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '5.16', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '2.96', 'spread': '0.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.49', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.34', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.24', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'FG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'FG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '284'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '284'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Of 668 consecutive patients with a positive heparin-PF4 ELISA test, 226 were excluded, primarily due to lack of recent heparin exposure. Of 442 eligible patients, 71 had HIT-T, 284 had Isolated HIT and 87 had no HIT.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '284', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '442', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'HIT-T', 'description': 'Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.'}, {'id': 'BG001', 'title': 'Isolated HIT', 'description': 'Positive heparin-PF4 ELISA test and a nadir platelet count \\<50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of \\>15% beginning within 5-10 days after starting heparin), without a thrombotic event.'}, {'id': 'BG002', 'title': 'No HIT', 'description': 'Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '16', 'groupId': 'BG000'}, {'value': '59', 'spread': '18', 'groupId': 'BG001'}, {'value': '60', 'spread': '19', 'groupId': 'BG002'}, {'value': '60', 'spread': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '223', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Platelet Count', 'classes': [{'categories': [{'measurements': [{'value': '282', 'spread': '268', 'groupId': 'BG000'}, {'value': '270', 'spread': '149', 'groupId': 'BG001'}, {'value': '215', 'spread': '172', 'groupId': 'BG002'}, {'value': '261', 'spread': '158', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'x 10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heparin exposure this admission before Day 0: use (or non-use) of unfractionated heparin (UFH)', 'classes': [{'title': 'Use of unfractionated heparin', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '263', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '409', 'groupId': 'BG003'}]}]}, {'title': 'Non-use of unfractionated heparin', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). Unfractionated heparin (UFH) has been used for the prevention and treatment of thrombosis for several decades.', 'unitOfMeasure': 'participants'}, {'title': 'Heparin exposure this admission before Day 0: use (or non-use) of low molecular weight heparin', 'classes': [{'title': 'Use of low molecular weight heparin', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}, {'title': 'Non-use of low molecular weight heparin', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '368', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). Low molecular weight heparin (LMWH) is derived from UFH by depolymerization. Each LMWH product has a specific molecular weight distribution that determines its anticoagulant activity and duration of action.', 'unitOfMeasure': 'participants'}, {'title': 'Heparin-PF4 (platelet factor 4) OD (optical density) test results', 'classes': [{'title': 'Less than 1.0', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '258', 'groupId': 'BG003'}]}]}, {'title': 'Greater than or equal to 1.0', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '183', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': "The OD in the Heparin-PF4 OD test stands for optical density. The PF4 stands for platelet factor 4. The test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood.", 'unitOfMeasure': 'participants'}, {'title': 'Admitting service', 'classes': [{'title': 'CV/thoracic surgery', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}]}, {'title': 'Orthopedic surgery', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Other surgery', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Medicine', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Of 668 consecutive patients with a positive heparin-PF4 ELISA test, 225 were excluded, primarily due to lack of recent heparin exposure. Of 442 eligible patients, 71 had HIT-T, 284 had Isolated HIT and 87 had no HIT.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 668}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-06', 'studyFirstSubmitDate': '2010-08-06', 'resultsFirstSubmitDate': '2015-03-17', 'studyFirstSubmitQcDate': '2010-08-06', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-16', 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.', 'description': 'The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.'}, {'measure': 'Time to Occurrence of a Composite Triple Endpoint Consisting of Death, Limb Amputation/Gangrene, and New Thrombosis', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge or day 45, whichever occurred first.', 'description': 'The median survival time is reported by each group for the time to occurrence of a composite triple endpoint consisting of death, limb amputation/gangrene, and new thrombosis.'}], 'secondaryOutcomes': [{'measure': 'Time to Death', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.'}, {'measure': 'Time to Death', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The median survival time is reported by each group for the time to death.'}, {'measure': 'Time to Occurrence of Limb Amputation or Limb Gangrene', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'Due to the small number of events, the median or mean survival time could not be defined. Therefore, the number of subjects with limb amputation or limb gangrene was reported in "Outcome Measure Data Table".'}, {'measure': 'Time to Occurrence of Radiographically Confirmed Thromboembolism', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias. However, the median survival times could not be defined for all three groups, so the mean time was reported in "Outcome Measure Data Table".'}, {'measure': 'Time to Occurrence of Major Bleeding', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The mean time to an event is estimated by the area under the survival function. If the largest time is an event time, then the survival function goes to zero at that time, and the mean survival estimate is finite. Otherwise, the mean time cannot be estimated and may lead to a bias.'}, {'measure': 'Time to Occurrence of Major Bleeding', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'The median survival time is reported by each group for the time to occurrence of major bleeding.'}, {'measure': 'Proportion of Subjects With HIT With Thrombosis (HIT-T) and Isolated HIT', 'timeFrame': 'From the date 5 days before the positive heparin PF-4 antibody test was drawn to the date it was drawn', 'description': 'Proportion of subjects who, at the time the positive heparin PF-4 antibody test was drawn, were in each of the following categories:\n\n* Group 1: Those with thrombosis and or without thrombocytopenia (HIT-T): 16% of 442 subjects.\n* Group 2: Those with thrombocytopenia but not thrombosis (Isolated HIT): 64% of 442 subjects.\n* Group 3: Those with neither thrombocytopenia nor thrombosis (Neither HIT-T nor Isolated HIT): 20% of 442 subjects.'}, {'measure': 'Type of Heparin Exposure - Unfractionated Heparin (UFH)', 'timeFrame': 'Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn', 'description': 'Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). UFH has been used for the prevention and treatment of thrombosis for several decades.'}, {'measure': 'Type of Heparin Exposure - Low Molecular Weight Heparin (LMWH)', 'timeFrame': 'Hospital admission to date the positive heparin PF-4 antibody test was drawn, or 28 days prior to the date it was drawn, whichever is later, through the date it was drawn', 'description': 'Two types of heparins are commonly used as anticoagulants - unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). LMWHs are derived from UFH by depolymerization. Each LMWH product has a specific molecular weight distribution that determines its anticoagulant activity and duration of action.'}, {'measure': 'Relationship of the Heparin PF-4 (Platelet Factor 4) Antibody Titer to the Clinical Diagnosis', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': "Heparin PF-4 (platelet factor 4) optical density (OD) test results were the dichotomous outcome (\\<1.0 vs. \\>=1.0). Clinical diagnosis was three groups (HIT-T, Isolated HIT and No HIT). The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood."}, {'measure': 'Relationship of the Heparin PF-4 Antibody Titer to the Degree of Thrombocytopenia', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': "Heparin PF-4 optical density (OD) test results were the dichotomous outcome (\\<1.0 vs. \\>=1.0). Nadir Platelet Count (x10\\^9 / L) was used for the degree of thrombocytopenia. The Heparin PF-4 optical density test looks for antibodies to complexes of heparin combined with platelet factor 4. Higher optical density indicates higher antibody concentration. We could say that generally OD values above 0.4 are considered a positive result, and that the higher the OD, the greater the concentration of antibodies in the patient's blood."}, {'measure': 'Relationship of the Heparin PF-4 Antibody Titer to the Primary Endpoint', 'timeFrame': 'From the time the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'Heparin PF-4 OD test results were the dichotomous outcome (\\<1.0 vs. \\>=1.0). Primary endpoint was the composite endpoint of death, limb amputation/gangrene, or new thrombosis.'}, {'measure': 'Use of Treatment (Non-heparin Anticoagulant) Used in Hospital', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first', 'description': 'Types of treatment (direct thrombin inhibitor, fondaparinux, warfarin, no treatment) provided to subjects in hospital'}, {'measure': 'Use of Treatment (Non-heparin Anticoagulant) Used at the Time of Discharge', 'timeFrame': 'From the time that the positive heparin PF-4 antibody test was drawn until hospital discharge, death, or day 45, whichever occurred first'}, {'measure': 'Time to Platelet Recovery, Among Subjects With a Low Platelet Count When the Positive PF4 Antibody Test Was Drawn', 'timeFrame': 'From the time that the nadir platelet count was drawn until hospital discharge, death, or day 45, whichever occurred first'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Thrombocytopenia', 'Heparin'], 'conditions': ['Heparin Induced Thrombocytopenia']}, 'descriptionModule': {'briefSummary': "HIT-RADIO is a study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals. The study will collect and analyse information that is already in the patients' medical records. Information about laboratory values (such as platelet counts), treatments (such as medications), and outcomes (such as blood clots, amputation, and death) will be included.", 'detailedDescription': 'HIT-RADIO is a retrospective chart-review study of patients who had a positive heparin PF-4 antibody test between 1/21/2008 and 9/25/2008 at selected hospitals associated with the Transfusion Medicine/Hemostasis Clinical Trials Network .\n\nHeparin-induced thrombocytopenia (HIT) is a major complication of the administration of heparin and can result in life-threatening thrombosis with or without thrombocytopenia (HIT-T) or can produce thrombocytopenia without clinically symptomatic thrombosis ("isolated" HIT). Isolated heparin-induced thrombocytopenia is defined as a fall in platelet count associated with a positive heparin PF-4 antibody test, in the absence of clinically overt thrombosis. While the treatment of HIT-T (HIT with thrombosis) with anticoagulation is well established, the risks and treatment of isolated HIT are unclear.\n\nIt is anticipated that this data analysis will provide a current overview of the implications of a positive heparin PF-4 antibody test in clinical practice. It should determine the percentage of positive heparin PF-4 antibody tests that are associated with thrombocytopenia and thrombosis (HIT-T) or "isolated" HIT at diagnosis and the subsequent major clinical outcomes of death, limb amputation/gangrene, and new thrombosis. No "snapshot" of such HIT patients has been conducted in the past decade and the results will be important in assessing the impact of HIT in current medical care as well as documenting current treatment strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with a positive heparin PF-4 antibody test drawn between 1/21/2008 and 9/25/2008', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects with a positive heparin PF-4 antibody test occurring between 1/21/2008 and 9/25/2008\n* Medical record available for the admission during which the positive heparin PF-4 antibody test was obtained\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01178333', 'acronym': 'HIT-RADIO', 'briefTitle': 'Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study', 'organization': {'class': 'OTHER', 'fullName': 'Carelon Research'}, 'officialTitle': 'Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study (HIT-RADIO Study)', 'orgStudyIdInfo': {'id': '678'}, 'secondaryIdInfos': [{'id': 'U01HL072268', 'link': 'https://reporter.nih.gov/quickSearch/U01HL072268', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Greenebaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital, Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University School of Medicine', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '54601', 'city': 'La Crosse', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Gunderson Clinic', 'geoPoint': {'lat': 43.80136, 'lon': -91.23958}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53201', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Susan F Assmann, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carelon Research'}, {'name': 'David Kuter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Eliot Williams, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}, {'name': 'Kenneth Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Versiti'}, {'name': 'Ronald Go, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gunderson Clinic'}, {'name': 'Keith McCrae, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Ellis Neufeld, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'Lynne Uhl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}, {'name': 'Judith Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'James Bussel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cornell University'}, {'name': 'Thomas Ortel, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Jodi Segal, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Barbara Konkle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bloodworks'}, {'name': 'Cindy Leissinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University'}, {'name': 'Thomas Raife, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}, {'name': 'Ann Zimrin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland Greenebaum Cancer Center'}, {'name': 'Jeffrey McCullough, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'Nigel Key, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Bruce Sachais, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Joseph Kiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Institute for Transfusion Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carelon Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}