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

Sponsor
Medical University of Warsaw (Other)
Overall Status
Recruiting
CT.gov ID
NCT06124209
Collaborator
(none)
170
Enrollment
1
Location
2
Arms
27.9
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial
Actual Study Start Date :
Nov 4, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Significant postoperative bleeding [10 days]

      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

    Secondary Outcome Measures

    1. Postoperative complication [10 days]

      Occurance of complication assesed in Clavien-Dindo scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of General Transplant and Liver Surgery Warsaw Mazovian Voivodeship Poland 02-097

    Sponsors and Collaborators

    • Medical University of Warsaw

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paweł Rykowski, MD, Medical University of Warsaw
    ClinicalTrials.gov Identifier:
    NCT06124209
    Other Study ID Numbers:
    • BVI_202301
    First Posted:
    Nov 9, 2023
    Last Update Posted:
    Nov 9, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Paweł Rykowski, MD, Medical University of Warsaw
    tachosil
    liver transplantation
    vena cava inferior anastomosis
    fibrin sealant
    hemostasis
    Additional relevant MeSH terms:
    Death
    Fibrin Tissue Adhesive

    Study Results

    No Results Posted as of Nov 9, 2023