Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial
- Registration Number
- NCT06124209
- Lead Sponsor
- Medical University of Warsaw
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- age over 18
- elective liver transplantation
- informed consent to participate in the study
-decision to use packing during liver transplantation (bail out strategy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tachosil® used in Vena Cava Inferior anastomosis TachoSil Tachosil® used in Vena Cava Inferior anastomosis.
- Primary Outcome Measures
Name Time Method Significant postoperative bleeding 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
- Secondary Outcome Measures
Name Time Method Postoperative complication 10 days Occurance of complication assesed in Clavien-Dindo scale
Trial Locations
- Locations (1)
Department of General Transplant and Liver Surgery
🇵🇱Warsaw, Mazovian Voivodeship, Poland