Pathogen-Reduced vs Traditional Cryoprecipitate for Bleeding

Overseen By Robert DeSimone

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Cardiac transplant, Pediatric, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate perioperative period

210 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Melissa Cushing

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for adults undergoing cardiovascular surgery or liver transplant who will receive cryoprecipitate during the procedure. It excludes those not receiving this product, cardiac transplant patients, anyone given the wrong product, recipients of less than one pool of cryo, children under 18, and pregnant women.

Inclusion Criteria

I am an adult who will receive cryotherapy during my heart surgery or liver transplant within the next two years.

I have had heart or major blood vessel surgery.

Exclusion Criteria

I am not a cardiovascular surgery or liver transplant patient.

I have had a heart transplant surgery.

I have received less than 5 units of cryoprecipitate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either traditional cryo or PR cryo based on randomization protocol

Immediate perioperative period

During surgery

Follow-up

Participants are monitored for adverse events such as infections, transfusion reactions, and fevers

5 days

Post-surgery monitoring

Treatment Details

Interventions

• Pathogen-Reduced Cryoprecipitate
• Traditional Cryoprecipitate

Trial Overview The study compares pathogen-reduced cryoprecipitate with traditional cryoprecipitate in managing early bleeding during surgery. The aim is to see if immediate access to thawed blood products can prevent severe hemorrhage and reduce the need for additional transfusions.

Participant Groups

Group I: Patients given PR Cryo Experimental Treatment 1 Intervention

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 II: Patients given Traditional Cryo Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Cerus Corporation

Industry Sponsor

Trials

20

Recruited

4,800+