Fibrinogen Treatment for Liver Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two treatments to manage bleeding during liver transplants. It compares Intercept Fibrinogen Complex (IFC), which can be used immediately, with the standard Cryoprecipitate Antihemophilic Factor (AHF), which requires brief preparation. The goal is to determine if faster access to fibrinogen (a protein that aids blood clotting) can improve outcomes for liver transplant patients with bleeding issues. Suitable candidates include those with conditions like alcoholic cirrhosis or hepatitis C who are scheduled for a liver transplant. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they benefit more patients.
Will I have to stop taking my current medications?
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 Intercept Fibrinogen Complex (IFC) and Cryoprecipitate Antihemophilic Factor (AHF)?
Research has shown that Intercept Fibrinogen Complex (IFC) is generally easy for patients to handle. One study found that IFC reduced the time from ordering to receiving the treatment by 58%, making it quick to use during surgeries. This speed can be crucial when time is critical, such as in liver transplants. Another study in heart surgeries suggested that IFC effectively controls bleeding during operations.
Both IFC and the standard Cryoprecipitate Antihemophilic Factor (AHF) have FDA approval, indicating they have been tested for safety. While specific side effects are not detailed in the available sources, their approval suggests they meet safety standards. However, discussing any concerns with the trial team or a healthcare provider is always advisable.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about Intercept Fibrinogen Complex (IFC) because it offers a faster and more efficient alternative to the standard Cryoprecipitate Antihemophilic Factor (AHF) used in liver transplants. Unlike AHF, which requires thawing time before use, IFC is readily available in the operating room, eliminating delays and potentially improving patient outcomes during surgery. This immediacy can be crucial in critical situations where time is of the essence, making IFC a promising option for enhancing the standard care in liver transplants.
What evidence suggests that this trial's treatments could be effective for liver transplant patients with bleeding and hypofibrinogenemia?
In this trial, participants will receive either Intercept Fibrinogen Complex (IFC) or Cryoprecipitate Antihemophilic Factor (AHF) during liver transplant procedures. Research has shown that IFC can significantly speed up treatment, reducing wait time from about 30 minutes to just under 15 minutes. Quick access to fibrinogen, a protein that aids in blood clotting, is crucial during liver transplants to control bleeding. Studies have found that low fibrinogen levels can lead to severe bleeding and increase the risk of death. IFC is designed to rapidly provide fibrinogen, potentially improving patient outcomes by making this vital blood component available more quickly. This suggests that using IFC might help manage bleeding more effectively in liver transplant patients.14678
Are You a Good Fit for This Trial?
This trial is for liver transplant patients who are bleeding and have low fibrinogen levels (hypofibrinogenemia). It's a pilot study to see which treatment helps control bleeding better during surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Intercept Fibrinogen Complex (IFC) or Standard Cryoprecipitate Antihemophilic Factor (AHF) during liver transplant surgery to manage bleeding and hypofibrinogenemia
Immediate Post-operative Monitoring
Participants are monitored for the amount of blood products administered and changes in viscoelastic parameters within 24 hours post-intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cryoprecipitate Antihemophilic Factor (AHF)
- Intercept Fibrinogen Complex (IFC)
Trial Overview
The trial compares two treatments: Intercept Fibrinogen Complex (IFC) and Standard Cryoprecipitate Antihemophilic Factor (AHF). Patients will be randomly assigned to receive one of these products to manage bleeding during their liver transplant.
How Is the Trial Designed?
2
Treatment groups
Active Control
AHF is the standard of care fibrinogen product often used in liver transplant cases. The procedures to use AHF include requesting the order of this product and then waiting for the product to be thawed for use, which can take approximately 10-15 minutes. Subjects assigned to this group will receive all standard of care procedures, including the use of AHF if required during their scheduled surgery.
IFC is an approved fibrinogen product that is not typically stored in the OR for liver transplant cases. Subjects assigned to this group will receive standard of care procedures, with the addition of IFC being readily available in their designated OR to eliminate any delay if they are to require the use of a fibrinogen product.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Trauma Hemostatis and Oxygenation Research (THOR) Network
Lead Sponsor
Citations
NCT06764927 | Fibrinogen in Liver Transplant Subjects
Observational data indicates the use of cryoprecipitate as a source of fibrinogen may reduce bleeding and improve outcomes in patients with severe bleeding.
Analyzing and modeling massive transfusion strategies ...
Fibrinogen level below 200 mg dL−1 is an independent risk factor for severe hemorrhage in trauma, cardiovascular, liver transplant, and ...
Implementation and early outcomes with Pathogen ...
Conclusions: There has been a substantial decrease in waste with improved turnaround time after IFC implementation. This has improved blood bank ...
4.
intercept-usa.com
intercept-usa.com/wp-content/uploads/2024/05/AABB23-Poster-P-TS-40-Stanford-Implementation-and-Quality-Analysis-of-PRCFC-STAMPED.pdfImplementation & Quality Analysis of Pathogen Reduced ...
There is also evidence that suggests low fibrinogen levels are associated with higher rates of mortality in traumatic bleeding and there may be a potential ...
5.
researchgate.net
researchgate.net/publication/382021885_Implementation_and_early_outcomes_with_Pathogen_Reduced_Cryoprecipitated_Fibrinogen_ComplexImplementation and early outcomes with Pathogen ...
A single-center study indicated that use of Intercept Fibrinogen Complex reduced time from order to treatment by 58% (30.4 to 14.6 minutes).
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
Study Details | NCT05711524 | Transfusion of Pathogen ...
Immediately replacing fibrinogen in perioperative bleeding patients with acquired fibrinogen deficiency improves outcomes. The product that is primarily used ...
Variable practices observed from July 2016 to June 2021, ...
Cryo production and usage data were collected over 5 years from July 1, 2016, to June 30, 2021, from nationally based blood collection centers ...
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