THROMBELASTOGRAPHY and Liver Graft FunctionsTGFNCT02336191
Monitoring Living Donor Liver Functions by Thromboelastometry
An observational study of THROMBELASTOGRAPHY and Liver Graft Functions, run by Mansoura University at 1 site in Egypt.
Trial summary
A prospective Observational study including 50 living donor liver transplant recipients to monitor the graft functions through thromboelastometry Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- THROMBELASTOGRAPHY and Liver Graft Functions
- What is being tested?
- living donor liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Living donor liver transplant recipients operated upon in mansoura university liver transplantion project
Who may be able to join
- Living donor liver transplant recipients successively performed in the liver transplantation program - Mansoura university
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gastroenerology Surgical Center - Liver transplantation program
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: 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
Read the 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.
- Being tested
- living donor liver transplantation
- Keywords
- living donor liver transplantation, graft function, thromboelastometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
living donor liver transplantationProcedure or surgery
living donor liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| LDLT Recipients | Patients subjected to living donor liver transplantation Receives: Procedure: living donor liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 20 minutes after the start of the TEG test
r (correlation coefficient) between clotting time , clot firmness time at 20 minutes and serum SGPT
Measured: 20 minutes after the start of the TEG test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THROMBELASTOGRAPHY and Liver Graft FunctionsStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr M. Yassen, Mansoura University
- Investigators
- amr M Yassen, MD, Principal investigator, MAnsoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336191
- Sponsor's protocol ID
- MansouraU_LDLT_TEG
- Acronym
- TGF
- Status last verified
- Aug 2015
- First submitted
- 3 Jan 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Post-transplant Living Donor Liver Functions by Thromboelastometry. A Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT02336191
- Acronym / sponsor ID
- TGF / MansouraU_LDLT_TEG
- Keywords
- living donor liver transplantation, graft function, thromboelastometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDLT Recipients | – | Procedure: living donor liver transplantationPatients subjected to living donor liver transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Living donor liver transplant recipients operated upon in mansoura university liver transplantion project
Key inclusion criteria (1 listed)
- Living donor liver transplant recipients successively performed in the liver transplantation program - Mansoura university
Key exclusion criteria (1 listed)
- Non
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| living donor liver transplantationliving donor liver transplantation | Procedure or surgery | LDLT Recipients |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
amr M Yassen, MD principal investigator
MAnsoura Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of THROMBELASTOGRAPHY and Liver Graft Functions, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
r (correlation coefficient) between clot firmness time at 20 minutes, clotting time and INR (time frame: 20 minutes after starting the TEG test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.