Monitoring Living Donor Liver Functions by Thromboelastometry (TGF)

March 24, 2017 updated by: Amr M. Yassen, Mansoura University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Gastroenerology Surgical Center - Liver transplantation program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Living donor liver transplant recipients operated upon in mansoura university liver transplantion project

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Non

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LDLT Recipients
Patients subjected to living donor liver transplantation
Procedure: living donor liver transplantation
living donor liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
r (correlation coefficient) between clot firmness time at 20 minutes, clotting time and INR
Time Frame: 20 minutes after starting the TEG test
Both blood sample for INR and other lab test and the sample for TEG will be simultaneously drawn from the arterial line for reading of days 0,1 and 2 then from the CVP for the rest of the study readings
20 minutes after starting the TEG test

Secondary Outcome Measures

Outcome Measure
Time Frame
r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum bilirubin
Time Frame: 20 minutes after the start of the TEG test
20 minutes after the start of the TEG test
r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum SGPT
Time Frame: 20 minutes after the start of the TEG test
20 minutes after the start of the TEG test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Amr M Yassen, MD, Mansoura Faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 3, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MansouraU_LDLT_TEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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