Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion

NCT ID: NCT06535360

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRT PLTs stored in PAS

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

Group Type: EXPERIMENTAL

Platelet transfusion

Intervention Type: BIOLOGICAL

platelet administration through intravenous access

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

FDA approved and already used in this patient population

Group Type: ACTIVE_COMPARATOR

Platelet transfusion

Intervention Type: BIOLOGICAL

platelet administration through intravenous access

Interventions

Platelet transfusion

platelet administration through intravenous access

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Magali Fontaine

Professor of Pathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magali Fontaine, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00088613

Identifier Type: -

Identifier Source: org_study_id