Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion

Phase 4

Completed

• Conditions: Cardiopulmonary Bypass Surgery
• Interventions: Biological: Platelet transfusion

• Registration Number: NCT06535360
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-07-30
• Status Verified: 2024-08
• Study First Posted: 2024-08-02
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-PRT PLTs stored in platelet additive solution (PAS)	Platelet transfusion	FDA approved and already used in this patient population
PRT PLTs stored in PAS	Platelet transfusion	FDA approved and already used in this patient population tested for non-inferiority

Primary Outcome Measures

Name	Time	Method
Change in Maximum Amplitude (MA) of thromboelastography (TEG)	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)

Secondary Outcome Measures

Name	Time	Method
Chest Tube Drainage	24 hours	The volume in ml of chest tube drainage during the first 24 hours post surgery
Red blood cell units Transfused	Within the first 24 Hrs Following Surgery	number of red blood cell units transfused
Plasma Units Transfused	Within the first 24 Hrs Following Surgery	number of plasma units transfused
Platelet Units Transfused	Within the first 24 Hrs Following Surgery	number of platelet units transfused
Cryoprecipitate Units Transfused	Within the first 24 Hrs Following Surgery	number of Cryoprecipitate Units Transfused

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States