Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-01 @ 7:34 AM
Study NCT ID:
NCT00948792
Status:
COMPLETED
Last Update Posted:
2011-07-12
First Post:
2009-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Effect of Differing Platelet Transfusion Times in Neonates
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': 'douglas-dannaway@ouhsc.edu', 'phone': '4052715215', 'title': 'Doug Dannaway', 'phoneExt': '42048', 'organization': 'University of Oklahoma Health Sciences Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.', 'eventGroups': [{'id': 'EG000', 'title': 'Long Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Short Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Post-transfusion Platelet Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'transfusions', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.'}, {'id': 'OG001', 'title': 'Short Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '-19', 'upperLimit': '442'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '260'}]}]}], 'analyses': [{'pValue': '0.8', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis is that there would be no difference in post-transfusion platelet counts (30-minutes post-transfusion) between the two groups.\n\nWe opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline-30 minutes after transfusion', 'description': 'The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.', 'unitOfMeasure': 'Platelets (*10^3/mm^3)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'transfusions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.'}, {'type': 'PRIMARY', 'title': 'Change in Post-transfusion Platelet Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Transfusions', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.'}, {'id': 'OG001', 'title': 'Short Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '316'}, {'value': '104', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '294'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis is that there would be no difference in post-transfusion platelet counts (6-hour post-transfusion) between the two groups.\n\nWe opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline - 6 hours after transfusion', 'description': 'The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.', 'unitOfMeasure': 'Platelets (*10^3/mm^3)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Transfusions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.'}, {'type': 'PRIMARY', 'title': '30 Minute-6 Hour Difference in Platelet Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Transfusions', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.'}, {'id': 'OG001', 'title': 'Short Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.5', 'groupId': 'OG000', 'lowerLimit': '-110', 'upperLimit': '29'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-84', 'upperLimit': '81'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The null hypothesis is that there would be no difference in the change in post-transfusion platelet counts (30 minutes and 6 hours post-transfusion) between the two groups.\n\nWe opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '30 minutes - 6 hours after transfusion', 'unitOfMeasure': 'Platelets (*10^3/mm^3)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Transfusions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Short and Long Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or 2 hours (long).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Short and Long Transfusion Group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or two hours (long).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '.09', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Days', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-13', 'studyFirstSubmitDate': '2009-07-27', 'resultsFirstSubmitDate': '2011-02-21', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-13', 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Post-transfusion Platelet Counts', 'timeFrame': 'Baseline-30 minutes after transfusion', 'description': 'The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.'}, {'measure': 'Change in Post-transfusion Platelet Counts', 'timeFrame': 'Baseline - 6 hours after transfusion', 'description': 'The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.'}, {'measure': '30 Minute-6 Hour Difference in Platelet Counts', 'timeFrame': '30 minutes - 6 hours after transfusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['platelets', 'transfusion', 'thrombocytopenia'], 'conditions': ['Thrombocytopenia']}, 'referencesModule': {'references': [{'pmid': '12823341', 'type': 'BACKGROUND', 'citation': 'British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the use of platelet transfusions. Br J Haematol. 2003 Jul;122(1):10-23. doi: 10.1046/j.1365-2141.2003.04468.x. No abstract available.'}, {'pmid': '19117893', 'type': 'BACKGROUND', 'citation': 'Josephson CD, Su LL, Christensen RD, Hillyer CD, Castillejo MI, Emory MR, Lin Y, Hume H, Easley K, Poterjoy B, Sola-Visner M. Platelet transfusion practices among neonatologists in the United States and Canada: results of a survey. Pediatrics. 2009 Jan;123(1):278-85. doi: 10.1542/peds.2007-2850.'}, {'pmid': '14977890', 'type': 'BACKGROUND', 'citation': 'Murray NA, Roberts IA. Neonatal transfusion practice. Arch Dis Child Fetal Neonatal Ed. 2004 Mar;89(2):F101-7. doi: 10.1136/adc.2002.019760.'}, {'pmid': '12937037', 'type': 'BACKGROUND', 'citation': 'Roberts I, Murray NA. Neonatal thrombocytopenia: causes and management. Arch Dis Child Fetal Neonatal Ed. 2003 Sep;88(5):F359-64. doi: 10.1136/fn.88.5.f359.'}, {'pmid': '18684573', 'type': 'BACKGROUND', 'citation': "Sola-Visner M, Saxonhouse MA, Brown RE. Neonatal thrombocytopenia: what we do and don't know. Early Hum Dev. 2008 Aug;84(8):499-506. doi: 10.1016/j.earlhumdev.2008.06.004. Epub 2008 Aug 5."}, {'pmid': '18194380', 'type': 'BACKGROUND', 'citation': 'Strauss RG. How I transfuse red blood cells and platelets to infants with the anemia and thrombocytopenia of prematurity. Transfusion. 2008 Feb;48(2):209-17. doi: 10.1111/j.1537-2995.2007.01592.x. Epub 2008 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.', 'detailedDescription': '1. It is our hypothesis that the change in post-transfusion platelet counts of babies who receive platelets over 30 minutes (short transfusion group) will be significantly different from the change in babies who receive platelets over two hours (long transfusion group) when platelets are checked immediately after transfusion and 6 hours after the completion of transfusion.\n2. We also expect there to be significant differences in the platelet counts drawn thirty minutes after transfusion compared to the counts drawn 6 hours after the completion of the transfusion in either group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants with significant thrombocytopenia requiring a transfusion of platelets.\n\nExclusion Criteria:\n\n* Infants requiring extracorporeal membranous oxygenation.\n* Infants with congenital heart disease (other than patent foramen ovale or patent ductus arteriosus).\n* Babies diagnosed with neonatal alloimmune thrombocytopenia.'}, 'identificationModule': {'nctId': 'NCT00948792', 'briefTitle': 'Study of the Effect of Differing Platelet Transfusion Times in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'The Effect of Variable Platelet Transfusion Durations on Platelet Count in Thrombocytopenic Newborns', 'orgStudyIdInfo': {'id': '14626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Long transfusion group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.', 'interventionNames': ['Procedure: Long platelet transfusion']}, {'type': 'EXPERIMENTAL', 'label': 'Short transfusion group', 'description': 'This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.', 'interventionNames': ['Procedure: Short platelet transfusion']}], 'interventions': [{'name': 'Short platelet transfusion', 'type': 'PROCEDURE', 'description': '15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets administered over 30 minutes', 'armGroupLabels': ['Short transfusion group']}, {'name': 'Long platelet transfusion', 'type': 'PROCEDURE', 'description': '15cc/kg of non-centrifuged, non-refrigerated, leukoreduced, AB-negative pheresis platelets given over two hours.', 'armGroupLabels': ['Long transfusion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': "Children's Hospital of Oklahoma", 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Douglas Dannaway, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Doug Dannaway / Assistant Professor of Pediatrics', 'oldOrganization': 'University of Oklahoma Health Sciences Center'}}}}