A Phase 4 interventional study of Platelet transfusion in Cardiopulmonary Bypass Surgery, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
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.
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.
University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FDA approved and already used in this patient population tested for non-inferiority
Biological: Platelet transfusion
FDA approved and already used in this patient population
Biological: Platelet transfusion
platelet administration through intravenous access
Change in Maximum Amplitude (MA) of thromboelastography (TEG)
ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion)
Time frame: within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion
Chest Tube Drainage
The volume in ml of chest tube drainage during the first 24 hours post surgery
Time frame: 24 hours
Red blood cell units Transfused
number of red blood cell units transfused
Time frame: Within the first 24 Hrs Following Surgery
Platelet Units Transfused
number of platelet units transfused
Time frame: Within the first 24 Hrs Following Surgery
Cryoprecipitate Units Transfused
number of Cryoprecipitate Units Transfused
Time frame: Within the first 24 Hrs Following Surgery
Plasma Units Transfused
number of plasma units transfused
Time frame: Within the first 24 Hrs Following Surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore