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

NCT06124209 | Recruiting Phase 4

• 1 other identifier: BVI_202301
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplant; Complications

Keywords

tachosil; liver transplantation; vena cava inferior anastomosis; fibrin sealant; hemostasis

Outcome Measures

Primary Outcomes (1)

• Significant postoperative bleeding

  occurrence of significant postoperative bleeding within 10 days after surgery, defined as the occurrence of one of the following: 1. occurrence of hematoma larger than 100ml 2. transfusion of packed red blood cells after surgery 3. performing relaparotomy due to bleeding

  10 days

Secondary Outcomes (1)

• Postoperative complication

  10 days

Study Arms (2)

Tachosil® used in Vena Cava Inferior anastomosis

EXPERIMENTAL

Tachosil® used in Vena Cava Inferior anastomosis.

Drug: TachoSil

Control

NO INTERVENTION

Standard haemostatic treatment in HPB surgery.

Interventions

TachoSil DRUG

TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.

Also known as: fibrin sealant matrix, EU/1/04/277/001, TachoSil 9,5 x 4,8 cm, Collagen-Fibrin Patch

Tachosil® used in Vena Cava Inferior anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18
• elective liver transplantation
• informed consent to participate in the study

You may not qualify if:

• decision to use packing during liver transplantation (bail out strategy)

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of General Transplant and Liver Surgery

Warsaw, Mazovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Interventions

TachoSil

Study Officials

• Paweł Rykowski, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweł Rykowski, MD

CONTACT

+48 22 599 2359; pawel.rykowski@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: November 4, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: 5 years after study finish
• Access Criteria: scintific puropse only

Locations

PL (1)