Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-03-07 @ 4:05 PM
Study NCT ID:
NCT06535360
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2024-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017713', 'term': 'Platelet Transfusion'}], 'ancestors': [{'id': 'D016913', 'term': 'Blood Component Transfusion'}, {'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-02', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maximum Amplitude (MA) of thromboelastography (TEG)', 'timeFrame': 'within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion', 'description': 'ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion)'}], 'secondaryOutcomes': [{'measure': 'Chest Tube Drainage', 'timeFrame': '24 hours', 'description': 'The volume in ml of chest tube drainage during the first 24 hours post surgery'}, {'measure': 'Red blood cell units Transfused', 'timeFrame': 'Within the first 24 Hrs Following Surgery', 'description': 'number of red blood cell units transfused'}, {'measure': 'Platelet Units Transfused', 'timeFrame': 'Within the first 24 Hrs Following Surgery', 'description': 'number of platelet units transfused'}, {'measure': 'Cryoprecipitate Units Transfused', 'timeFrame': 'Within the first 24 Hrs Following Surgery', 'description': 'number of Cryoprecipitate Units Transfused'}, {'measure': 'Plasma Units Transfused', 'timeFrame': 'Within the first 24 Hrs Following Surgery', 'description': 'number of plasma units transfused'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiopulmonary Bypass Surgery']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution.', 'detailedDescription': 'The safety and efficacy of pathogen reduced (PRT) platelets (PLTs) have been investigated in several controlled clinical studies. Most of these clinical studies evaluated the efficacy of PRT PLTs during prophylactic transfusion evaluating post-transfusion platelet count increments, rather than platelet function during bleeding episodes. During massive transfusion events and immediate resuscitation, PLT transfusion is recognized as an important determinant of a positive patient outcome. PLT transfusion is important to control bleeding in patients undergoing cardiac surgery on cardiopulmonary bypass because cardiopulmonary bypass alters platelet function. Thus, transfusion of functional platelets is required to control bleeding post-operatively. In this context, the investigators propose to investigate whether efficient hemostasis associated with platelet transfusion differs with the use of pathogen reduced PRT PLTs compared to non-pathogen reduced PLTs that are suspended in platelet additive solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Preoperative evaluation for risk of transfusion: platelet count \\< 200,000/mcl, OR anticipated time on cardiopulmonary bypass \\> 90 min, OR complex cardiac surgery, OR use of preoperative antiplatelet therapy within 3-5 days of surgery.\n\nExclusion Criteria:\n\n* Patient that lack the ability to consent\n* Patients with the diagnosis of idiopathic thrombocytopenia purpura,\n* Patient with the diagnosis of heparin-induced thrombocytopenia.'}, 'identificationModule': {'nctId': 'NCT06535360', 'briefTitle': 'Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'HP-00088613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRT PLTs stored in PAS', 'description': 'FDA approved and already used in this patient population tested for non-inferiority', 'interventionNames': ['Biological: Platelet transfusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-PRT PLTs stored in platelet additive solution (PAS)', 'description': 'FDA approved and already used in this patient population', 'interventionNames': ['Biological: Platelet transfusion']}], 'interventions': [{'name': 'Platelet transfusion', 'type': 'BIOLOGICAL', 'description': 'platelet administration through intravenous access', 'armGroupLabels': ['Non-PRT PLTs stored in platelet additive solution (PAS)', 'PRT PLTs stored in PAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Magali Fontaine, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pathology', 'investigatorFullName': 'Magali Fontaine', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}