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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of blood products for controlling bleeding during surgeries: pathogen-reduced cryoprecipitate and traditional cryoprecipitate. The researchers seek to determine if pathogen-reduced cryoprecipitate can more effectively manage early bleeding in liver transplant and cardiovascular surgery patients, potentially reducing the need for additional blood products like platelets and plasma. Participants will receive one of these blood products during surgery. The trial seeks individuals undergoing cardiovascular surgery or a liver transplant who will receive cryoprecipitate during the procedure. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and it aims to understand how it benefits more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research shows that both pathogen-reduced cryoprecipitate and traditional cryoprecipitate are safe. Pathogen-reduced cryoprecipitate, a blood product treated to lower the risk of disease-causing germs, has been found effective and safe for raising fibrinogen levels, which aid in blood clotting.

Traditional cryoprecipitate, used for a long time, is also safe for replacing fibrinogen during bleeding. The FDA has approved both treatments, which are commonly used in medical settings. No major side effects have been reported for either, indicating they are well-tolerated by patients. This reliability makes both treatments a good choice for managing bleeding during surgeries like liver transplants and heart procedures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about pathogen-reduced cryoprecipitate because it offers a safer alternative to traditional cryoprecipitate for patients experiencing bleeding, particularly during liver transplants and cardiothoracic surgeries. Unlike traditional cryoprecipitate, which carries a risk of transmitting infections, pathogen-reduced cryoprecipitate undergoes a special process to inactivate viruses, bacteria, and other pathogens. This innovative approach aims to reduce complications related to blood transfusions, potentially making it a game-changer in surgical settings where bleeding control is critical.

What evidence suggests that this trial's treatments could be effective for bleeding?

This trial will compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate for treating sudden bleeding. Research has shown that pathogen-reduced cryoprecipitate effectively treats sudden bleeding, particularly in heart surgery patients. Studies have found that it helps replace fibrinogen, a protein essential for blood clotting, and improves outcomes for bleeding patients. This treatment is safe and reduces the need for additional blood products like platelets, plasma, and red blood cells. Pathogen-reduced cryoprecipitate is a trusted option for managing bleeding because it is readily accessible and can be used quickly when needed. ^{2 6 7 8 9}

Who Is on the Research Team?

Melissa Cushing

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 have had heart or major blood vessel surgery.

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

Exclusion Criteria

I am under 18 years old.

Patients who receive a product in error within either the cryo time period or the PR cryo time period

I am not a cardiovascular surgery or liver transplant patient.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11430273/

Trial Of Pathogen-reduced Cryoprecipitate vs ... This trial aims to provide evidence of the clinical efficacy of utilizing readily available thawed IFC during acute bleeding in the cardiac surgery setting

2. ashpublications.org ashpublications.org/blood/article/138/Supplement%201/3248/479085/Pathogen-Reduced-Cryoprecipitate-and-Fibrinogen

Pathogen Reduced Cryoprecipitate and Fibrinogen ... Fibrinogen replacement is crucial for improving outcomes in bleeding patients. The two most common clinically-used hemostatic adjuncts for ...

3. aabb.org aabb.org/news-resources/news/article/2024/10/22/aabb24--pathogen-reduced-cryoprecipitated-fibrinogen-complex-beneficial-for-treatment-of-acute-bleeding-in-patients-undergoing-cardiac-surgery

AABB24: Pathogen-Reduced Cryoprecipitated Fibrinogen ... Pathogen-reduced cryoprecipitated fibrinogen complex is a safe and effective option to treat acute bleeding in patients undergoing cardiac surgery.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07218185

Comparative Effectiveness of INTERCEPT Fibrinogen ... The objective of this study is to determine the feasibility and effectiveness of early IFC administration in patients with functional hypofibrinogenemia ...

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2799836

Cost-effectiveness of Fibrinogen Concentrate vs ... This study attempts to determine cost-effectiveness of fibrinogen concentrate vs cryoprecipitate for managing active bleeding in adult ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05711524

Study Details | NCT05711524 | Transfusion of Pathogen ... The goal of this quality improvement study is to compare pathogen-reduced cryoprecipitate with traditional cryoprecipitate in liver transplant and ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/24/NCT05711524/Prot_SAP_000.pdf

TITLE: Transfusion of Pathogen Reduced Cryoprecipitated ... Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1053077023008947?dgcid=rss_sd_all&

Prospective, Randomized Study of Fibrinogen Concentrate ... In conclusion, the results from this study showed that FC and cryoprecipitate were both effective for increasing plasma fibrinogen levels in patients requiring ...

9. cdn.who.int cdn.who.int/media/docs/default-source/essential-medicines/2023-eml-expert-committee/expert-reviews/a11_cryo-pr_rev2.pdf?sfvrsn=fb48611b_1

A.11 Cryoprecipitate (pathogen-reduced) Many clinical guidelines have recommended against the use of cryoprecipitate for replacement therapies in hemophilia A, FXIII deficiency, hypofibrinogenemia, ...