Clinical trial

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

Name

BVI_202301

Description

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.

Trial arms

Trial start

2023-11-04

Estimated PCD

2025-12-01

Trial end

2026-03-01

Status

Recruiting

Phase

Early phase I

Treatment

TachoSil

TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.

Arms:

Tachosil® used in Vena Cava Inferior anastomosis

Other names:

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

Size

170

Primary endpoint

Significant postoperative bleeding

10 days

Eligibility 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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 170, 'type': 'ESTIMATED'}}

Updated at

2024-02-28

1 organization

1 product

1 indication

Organization

Medical University of Warsaw

Product

TachoSil

Indication

Liver Transplant