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

February 26, 2024 updated by: Paweł Rykowski, Medical University of Warsaw

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Mazovian Voivodeship
      • Warsaw, Mazovian Voivodeship, Poland, 02-097
        • Recruiting
        • Department of General Transplant and Liver Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paweł Rykowski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tachosil® used in Vena Cava Inferior anastomosis
Tachosil® used in Vena Cava Inferior anastomosis.
Drug: TachoSil
TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.
Other Names:
  • fibrin sealant matrix
  • EU/1/04/277/001
  • TachoSil 9,5 x 4,8 cm
  • Collagen-Fibrin Patch
No Intervention: Control
Standard haemostatic treatment in HPB surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significant postoperative bleeding
Time Frame: 10 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complication
Time Frame: 10 days
Occurance of complication assesed in Clavien-Dindo scale
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Paweł Rykowski, MD, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 3, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVI_202301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonimized IPD would be shared after personal contact, after PI approval

IPD Sharing Time Frame

5 years after study finish

IPD Sharing Access Criteria

scintific puropse only

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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