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

Liver Transplant; Complications Clinical Trial

— HemoCava  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124209
• Other study ID #: BVI_202301
• Status: Recruiting
• Phase: Phase 4
• Start date: November 4, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Medical University of Warsaw
• Contact: Pawel Rykowski, MD
• Phone: +48 22 599 2359
• Email: pawel.rykowski[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Death
• Liver Transplant; Complications

Intervention

Drug:
• TachoSil
TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.

Locations

Country	Name	City	State
Poland	Department of General Transplant and Liver Surgery	Warsaw	Mazovian Voivodeship

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant postoperative bleeding	occurrence of significant postoperative bleeding within 10 days after surgery, defined as the occurrence of one of the following: occurrence of hematoma larger than 100ml; transfusion of packed red blood cells after surgery; performing relaparotomy due to bleeding	10 days
Secondary	Postoperative complication	Occurance of complication assesed in Clavien-Dindo scale	10 days