Liver Transplant; Complications
Conditions
Keywords
tachosil, liver transplantation, vena cava inferior anastomosis, fibrin sealant, hemostasis
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.
Interventions
DRUGTachoSil
TachoSil used in Vena Cava Inferior anastomosis during liver transplantation.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 strategy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complication | 10 days | Occurance of complication assesed in Clavien-Dindo scale |
Countries
Poland
Contacts
Primary ContactPaweł Rykowski, MD
Outcome results
None listed