Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion

NCT06535360 | Completed Phase 4 FDA Drug

• 1 other identifier: HP-00088613
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Chest Tube Drainage

  24 hours

• Red blood cell units Transfused

  Within the first 24 Hrs Following Surgery

• Platelet Units Transfused

  Within the first 24 Hrs Following Surgery

• Cryoprecipitate Units Transfused

  Within the first 24 Hrs Following Surgery

• Plasma Units Transfused

  Within the first 24 Hrs Following Surgery

Study Arms (2)

PRT PLTs stored in PAS

EXPERIMENTAL

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

Biological: Platelet transfusion

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

ACTIVE COMPARATOR

FDA approved and already used in this patient population

Biological: Platelet transfusion

Interventions

Platelet transfusion BIOLOGICAL

platelet administration through intravenous access

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

Platelet Transfusion

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Magali Fontaine, MD, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pathology

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: August 2, 2024
• Study Start: September 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)