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

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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Bypass Surgery
• Intervention / Treatment: Biological: Platelet transfusion

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRT PLTs stored in PAS; FDA approved and already used in this patient population tested for non-inferiority	Biological: Platelet transfusion; platelet administration through intravenous access
Active Comparator: Non-PRT PLTs stored in platelet additive solution (PAS); FDA approved and already used in this patient population	Biological: Platelet transfusion; platelet administration through intravenous access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Amplitude (MA) of thromboelastography (TEG)	ΔMA observed with platelet transfusion (difference in MA measured within an hour post transfusion to MA measured immediately pre-transfusion)	within 60 minutes including blood for TEG testing immediately pre transfusion and blood draw post transfusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Magali Fontaine, MD, PhD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HP-00088613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No