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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
platelet administration through intravenous access
University of Maryland Medical Center
Baltimore, Maryland, United States
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
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