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

NCT ID: NCT05711524

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-10-03

Brief 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.

Detailed 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.

Conditions

Hypofibrinogenemia; Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients given Traditional Cryo

These are the liver transplant and cardiothoracic (LT and CT) patients that will be given traditional cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.

Group Type: ACTIVE_COMPARATOR

Traditional Cryoprecipitate

Intervention Type: BIOLOGICAL

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

Patients given PR Cryo

These are the liver transplant and cardiothoracic (LT and CT) patients that will be given PR cryo based on the randomization protocol. The blood bank will alternate use of PR cryo and regular cryo each month for all patients with a cryo order. All patients will receive either traditional cryo or PR cryo in a given month.

Group Type: EXPERIMENTAL

Pathogen-Reduced Cryoprecipitate

Intervention Type: BIOLOGICAL

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

Interventions

Traditional Cryoprecipitate

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

Intervention Type: BIOLOGICAL

Pathogen-Reduced Cryoprecipitate

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

2. Cardiovascular surgery includes the following procedures:

1. coronary artery bypass grafting

2. valve repair or replacement

3. open thoracic aortic and thoracoabdominal aortic surgery

4. atrial or ventricular septal defects

5. ventricular assist device implantation or revision

6. or any combination of the above.

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 PR cryo time period. For example, PR cryo during a cryo month or cryo during a PR cryo time 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cerus Corporation

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Cushing

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Countries

United States

References

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Cushing MM, Haas T, Karkouti K, Callum J. Which is the preferred blood product for fibrinogen replacement in the bleeding patient with acquired hypofibrinogenemia-cryoprecipitate or fibrinogen concentrate? Transfusion. 2020 Jun;60 Suppl 3:S17-S23. doi: 10.1111/trf.15614. Epub 2020 Jun 1.

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Cushing MM, Cohen T, Fitzgerald MM, Rand S, Sinfort A, Chen D, Keltner N, Ong S, Parra P, Benabdessadek D, Jimenez A, Haas T, Lau C, Girardi NI, DeSimone RA. Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized trial. Trials. 2024 Sep 27;25(1):625. doi: 10.1186/s13063-024-08398-x.

Reference Type: DERIVED

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22-04024649

Identifier Type: -

Identifier Source: org_study_id