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

Phase 4

Active, not recruiting

• Conditions: Hypofibrinogenemia; Bleeding
• Interventions: Biological: Pathogen-Reduced Cryoprecipitate; Biological: Traditional Cryoprecipitate

• Registration Number: NCT05711524
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-03
• Study Start: 2023-04-01
• Primary Completion: 2024-10-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients given PR Cryo	Pathogen-Reduced Cryoprecipitate	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.
Patients given Traditional Cryo	Traditional Cryoprecipitate	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.

Primary Outcome Measures

Name	Time	Method
Total number of platelets used over admission	Within the first 30 days after surgery.
Total number of RBCs used over admission	Within the first 30 days after surgery.
Total number of plasma used over admission	Within the first 30 days after surgery.

Secondary Outcome Measures

Name	Time	Method
Number of cryo or fibrinogen concentrate products used perioperatively	3 days post procedure
Length of stay in hospital	During hospitalization, approximately 5 days to 30 days
Pre transfusion FIBTEM amplitude at 10mins	Within 10 minutes to one hour after the end of the first cryo transfusion.
Maximum clot firmness at 10mins	Within 10 minutes to one hour after the end of the first cryo transfusion.
Cumulative volume in drains after surgery (e.g., chest tube for CV surgery) at the time of removal	Up to approximately 3 days
Number of RBCs used perioperatively	3 days post procedure
Number of plasma used perioperatively	3 days post procedure
Time from cryo order to start of transfusion	procedure (Time from cryo order to start of transfusion)
Lowest fibrinogen level within 24 hours	Within 24 hours after surgery
Number of cryo units wasted by blood bank	Daily, up to approximately 24 months
Post transfusion FIBTEM amplitude at 10mins	Within 10 minutes to one hour after the end of the first cryo transfusion.
Number of platelets used perioperatively	3 days post procedure
Time from OR start time to start of cryo transfusion	procedure (Time from OR start time to start of cryo transfusion)
Highest fibrinogen level within 24 hours	Within 24 hours after surgery
Overall cost of cryo vs PR cryo, when factoring wastage	Daily, approximately 24 months
Number of adverse events: infections	Within 5 days of surgery start time	All infections that occur during the time frame
Fibrinogen level	Most proximal to end of procedure
Fibrinogen level at 10mins	Within 10 minutes to one hour after the end of the first cryo transfusion.
Volume in drains (e.g. chest tube for CV surgery)	At 24 hours after surgery
Time from end of bypass pump for CV surgery	Until end of surgery
Length of stay in ICU	During hospitalization, approximately 5 days to 30 days
Time on ventilator	During hospitalization, approximately 5 days to 30 days
Length of stay in OR	During hospitalization, approximately 5 days to 30 days
Need for ventilator	During hospitalization, approximately 5 days to 30 days
Number of adverse events: fevers	Within 5 days of surgery start time	All fevers that occur during the time frame
Number of adverse events: transfusion reactions	Within 5 days of surgery start time	All transfusion reactions that occur during the time frame

Trial Locations

Locations (1)

New York-Presbyterian Hospital/Weill Cornell Medical Center; 🇺🇸 New York, New York, United States