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

Last updated: May 14, 2025
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Not Recruiting

Phase

4

Condition

Hemorrhage

Treatment

Pathogen-Reduced Cryoprecipitate

Traditional Cryoprecipitate

Clinical Study ID

NCT05711524
22-04024649
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients undergoing cardiovascular surgery or liver transplant who receivecryo during surgery during the two year study period.

  2. Cardiovascular surgery includes the following procedures:

  3. coronary artery bypass grafting

  4. valve repair or replacement

  5. open thoracic aortic and thoracoabdominal aortic surgery

  6. atrial or ventricular septal defects

  7. ventricular assist device implantation or revision

  8. or any combination of the above.

Exclusion

Exclusion Criteria:

  1. Patients who do not receive any cryo product in the OR

  2. Patients who are not cardiovascular surgery or liver transplant patients

  3. Cardiac transplantation surgery

  4. Patients who receive a product in error within either the cryo time period or the PRcryo time period. For example, PR cryo during a cryo month or cryo during a PR cryotime month.

  5. Patients who receive less than 1 pool (5 units) of cryo

  6. Pediatric patients (less than 18 years of age).

  7. Patients who received both PR cryo and traditional cryo

  8. Pregnant women

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Pathogen-Reduced Cryoprecipitate
Phase: 4
Study Start date:
April 01, 2023
Estimated Completion Date:
September 30, 2025

Study Description

Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used for fibrinogen replacement in the US, cryoprecipitate (cryo), must be stored frozen and expires six hours after thawing, resulting in a delay in transfusion of approximately 50 minutes from the time it is ordered, as well as unnecessary transfusion of more readily available but not indicated blood components that are transfused while the patients waits for cryo . A modified version of the product, pathogen reduced (PR) cryo, is now FDA approved and can be thawed and stored for 5 days, allowing the product to be available immediately when needed. In this quality improvement study, the investigators will compare the effect that readily available, pre-thawed PR cryo has on transfusion practice in cardiovascular and liver transplant patients who receive PR cryo versus those who receive traditional cryo by randomizing cryo transfusions in the blood bank by month to all cryo or all PR cryo. All clinical decisions, including the need for cryo, and laboratory testing will occur per standard of care.

Connect with a study center

  • New York-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

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