Monitoring Post-transplant Living Donor Liver Functions by Thromboelastometry. A Prospective Observational Study.

Monitoring Living Donor Liver Functions by Thromboelastometry

Sponsors

Lead sponsor: Mansoura University

Source Mansoura University
Brief Summary

A prospective Observational study including 50 living donor liver transplant recipients to monitor the graft functions through thromboelastometry

Detailed Description

This is a prospective observational study Includes 50 living donor liver transplant recipients performed in gastroenterology surgical center - Mansoura University liver transplantation program.

Study period: from June 2014 to May 2015 The early post-operative graft functions will be correlated with concomitant monitored thromboelastometric (TEM) parameters derived from a ROTEM Delt device

TEM Samples will be collected at the following times:

Pre-transplant 10 minutes post portal declamping at ICU admission Morning of Days from 1 to 7 Laboratory data relevant to graft functional status will be collected at the same times.

Overall Status Completed
Start Date June 2014
Completion Date August 2015
Primary Completion Date April 2015
Study Type Observational
Primary Outcome
Measure Time Frame
r (correlation coefficient) between clot firmness time at 20 minutes, clotting time and INR 20 minutes after starting the TEG test
Secondary Outcome
Measure Time Frame
r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum bilirubin 20 minutes after the start of the TEG test
r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum SGPT 20 minutes after the start of the TEG test
Enrollment 50
Condition
Intervention

Intervention type: Procedure

Intervention name: living donor liver transplantation

Description: living donor liver transplantation

Arm group label: LDLT Recipients

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Living donor liver transplant recipients successively performed in the liver transplantation program - Mansoura university

Exclusion Criteria:

- Non

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
amr M Yassen, MD Principal Investigator MAnsoura Faculty of Medicine
Location
facility
Gastroenerology Surgical Center - Liver transplantation program
Location Countries

Egypt

Verification Date

August 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Mansoura University

Investigator full name: Amr M. Yassen

Investigator title: Professor of Anesthesia and Intensive Care

Keywords
Has Expanded Access No
Arm Group

Arm group label: LDLT Recipients

Description: Patients subjected to living donor liver transplantation

Acronym TGF
Patient Data No
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov