Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion

University of Maryland Baltimore (UMB)

Status and phase: Completed; Phase 4

Conditions: Cardiopulmonary Bypass Surgery

Treatments: Biological: Platelet transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06535360

HP-00088613

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Preoperative evaluation for risk of transfusion: platelet count < 200,000/mcl, OR anticipated time on cardiopulmonary bypass > 90 min, OR complex cardiac surgery, OR use of preoperative antiplatelet therapy within 3-5 days of surgery.

Exclusion criteria

• Patient that lack the ability to consent
• Patients with the diagnosis of idiopathic thrombocytopenia purpura,
• Patient with the diagnosis of heparin-induced thrombocytopenia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

PRT PLTs stored in PAS

Experimental group

Description:

FDA approved and already used in this patient population tested for non-inferiority

Treatment:

Biological: Platelet transfusion

Non-PRT PLTs stored in platelet additive solution (PAS)

Active Comparator group

Description:

FDA approved and already used in this patient population

Treatment:

Biological: Platelet transfusion