NCT06124209

Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor. The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.

Detailed description

Studies have shown that materials containing fibrin shorten the time to hemostasis in the case of planned liver resection, but did not show a significant effect on the occurrence of postoperative bleeding. The aim of the study is to supplement knowledge about hemostatic matrices in liver transplantation, which will be used for the inferior vena cava anastomosis. The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor. The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.

Conditions

• Liver Transplant; Complications

Interventions

Type	Name	Description
DRUG	TachoSil	TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.

Timeline

• Start date: 2023-11-04
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2023-11-09
• Last updated: 2024-02-28

Locations

1 site across 1 country: Poland