University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
NCT Number: NCT06535360
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Baltimore, Maryland, 21201, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
platelet administration through intravenous access
Time frame: within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion
ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion)
Time frame: 24 hours
The volume in ml of chest tube drainage during the first 24 hours post surgery
Time frame: Within the first 24 Hrs Following Surgery
number of red blood cell units transfused
Time frame: Within the first 24 Hrs Following Surgery
number of platelet units transfused
Time frame: Within the first 24 Hrs Following Surgery
number of Cryoprecipitate Units Transfused
Time frame: Within the first 24 Hrs Following Surgery
number of plasma units transfused
University of Maryland, Baltimore
Other
Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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