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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT PLTs stored in PAS | Experimental | FDA approved and already used in this patient population tested for non-inferiority |
|
| Non-PRT PLTs stored in platelet additive solution (PAS) | Active Comparator | FDA approved and already used in this patient population |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet transfusion | Biological | platelet administration through intravenous access |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Chest Tube Drainage | The volume in ml of chest tube drainage during the first 24 hours post surgery | 24 hours |
| Red blood cell units Transfused | number of red blood cell units transfused |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magali Fontaine, MD, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 2, 2026 | Mar 23, 2026 | 2 |
| ID | Term |
|---|---|
| D017713 | Platelet Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Within the first 24 Hrs Following Surgery |
| Platelet Units Transfused | number of platelet units transfused | Within the first 24 Hrs Following Surgery |
| Cryoprecipitate Units Transfused | number of Cryoprecipitate Units Transfused | Within the first 24 Hrs Following Surgery |
| Plasma Units Transfused | number of plasma units transfused | Within the first 24 Hrs Following Surgery |