Using a fibrin sealant patch for vein connections in liver transplants
Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial
This study is testing if a special patch can help make better connections in veins during liver transplants to reduce complications for patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw, Mazovian Voivodeship) |
| Trial ID | NCT06124209 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a hemostatic matrix containing fibrinogen and thrombin (TachoSil®) on the anastomosis of the inferior vena cava during liver transplantation from deceased donors. Participants are divided into two groups: one receiving the fibrin sealant on the anastomotic line and the other receiving standard hemostasis without the matrix. The study aims to determine if the use of TachoSil® can improve hemostasis and reduce complications during the transplantation process. A total of 170 patients will be enrolled, with 85 in each group.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are undergoing elective liver transplantation.
Not a fit: Patients who require a bail-out strategy involving packing during liver transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical outcomes and reduce complications in liver transplantation.
How similar studies have performed: Previous studies have shown that fibrin-based materials can improve hemostasis in liver surgeries, but their specific application in liver transplantation is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age over 18 * elective liver transplantation * informed consent to participate in the study Exclusion Criteria: -decision to use packing during liver transplantation (bail out strategy)
Where this trial is running
Warsaw, Mazovian Voivodeship
- Department of General Transplant and Liver Surgery — Warsaw, Mazovian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Paweł Rykowski, MD — Medical University of Warsaw
- Study coordinator: Paweł Rykowski, MD
- Email: pawel.rykowski@wum.edu.pl
- Phone: +48 22 599 2359
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.