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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06124209
Other study ID # BVI_202301
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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