NCT02336191

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

March 28, 2017

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

January 3, 2015

Last Update Submit

March 24, 2017

Conditions

THROMBELASTOGRAPHY and Liver Graft Functions

Keywords

living donor liver transplantationgraft functionthromboelastometry

Outcome Measures

Primary Outcomes (1)

  • r (correlation coefficient) between clot firmness time at 20 minutes, clotting time and INR

    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 Outcomes (2)

  • 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

Study Arms (1)

LDLT Recipients

Patients subjected to living donor liver transplantation

Procedure: living donor liver transplantation

Interventions

living donor liver transplantationPROCEDURE

living donor liver transplantation

LDLT Recipients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Non

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenerology Surgical Center - Liver transplantation program

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Officials

  • amr M Yassen, MD

    MAnsoura Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

January 3, 2015

First Posted

January 12, 2015

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

August 1, 2015

Last Updated

March 28, 2017

Record last verified: 2015-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)