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Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding

NCT05711524 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-11-21

Study results available
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Summary

The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and cardiovascular patients. The investigators hypothesize that by having immediate access to a readily available thawed blood product that replaces fibrinogen (the main substrate of a blood clot), early bleeding can be treated before it escalates into uncontrolled hemorrhage, and therefore additional blood products, like platelets, plasma and red blood cells can be avoided.

Participants will be given one of the two FDA-approved blood products.

Conditions

Interventions

BIOLOGICAL

Traditional Cryoprecipitate

This is the cryoprecipitate already currently being given to patients with a cryo order.

BIOLOGICAL

Pathogen-Reduced Cryoprecipitate

This is the pathogen-reduced cryoprecipitate that is intended to be compared to the standard cryoprecipitate.

Sponsors & Collaborators

  • Cerus Corporation

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Melissa Cushing · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-10-23
Completion
2025-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05711524 on ClinicalTrials.gov