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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Transplant; Complications

Intervention / Treatment
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* Drug: TachoSil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tachosil® used in Vena Cava Inferior anastomosis<br>Tachosil® used in Vena Cava Inferior anastomosis. | Drug: TachoSil<br>* TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.<br>* Other names: Collagen-Fibrin Patch;|
| No Intervention: Control<br>Standard haemostatic treatment in HPB surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tachosil, liver transplantation, vena cava inferior anastomosis, fibrin sealant, hemostasis