NCT06535360

Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion

Improving Efficacy and Safety of Pathogen Inactivation Strategies for Platelet Transfusion in Cardiac Surgical Patients on Cardiopulmonary Bypass

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiopulmonary Bypass Surgery

Interventions

Type	Name	Description
BIOLOGICAL	Platelet transfusion	platelet administration through intravenous access

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2024-08-02
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study