Ischemia Reperfusion InjuryPNPNCT02540447

Purge Vs no Purge in Living Donor Liver Transplantation Recipients

A study testing Purge in people with Ischemia Reperfusion Injury, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The investigators tested the impact of purging the graft contents and mesenteric blood into the systemic circulation versus washing out this volume out of the circulation in living donor liver transplantation recipients. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Ischemia Reperfusion Injury
What is being tested?: Purge
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteEgypt
Study dates: Jan 2013to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Adult living donor liver transplantation recipients of either sex in mansoura liver transplantation program

Who cannot join

re-transplantation
Previous upper abdominal operation
Budd Chiari syndrome

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Liver transplantation project - Gastroenterology surgical center - Mansoura university
Al Mansurah, Dakahlia Governorate, 35511

Other trials in Egypt

About this study

Official title: Graft Portal Reperfusion Without Purging Graft Preservative Solution In Living Donor Liver Transplantation. A Prospective Randomized Controlled Trial

Read the detailed description

All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4 Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg) (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg) (n=40) where graft fluid contents were washed into the systemic circulation by the patient's portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes after portal declamping. Secondary objectives included hemodynamic and oxygenation.

Conditions: Ischemia Reperfusion Injury
Being tested: Purge
Keywords: Liver transplantation, Graft rinse, Ischemia reperfusion injury
Medical subject headings: Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PurgeProcedure or surgery
In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping

Study groups in NCT02540447
Study group	Role	What they receive
Purge	Experimental	The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis. Receives: Procedure: Purge
No Purge	No intervention	The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.

What is being measured

The primary outcome is the main question the study is designed to answer.

Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure
The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping
Measured: 5 minutes post-reperfusion

Secondary outcomes (4)

Biliary Complications (Participants)
Participants who developed biliary complications in three months period (Participant)
Measured: 3 months
Ischemia Reperfusion Injury
incidence of ischemia reperfusion injury in the transplanted graft
Measured: 7 days
Post-operative Infectious Complications
Measured: 30 days
3 Months Mortality
mortality within first 3 post-operative months
Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013May 2015

First posted4 Sep 2015 (estimated)
Study startJan 2013
Primary completionMay 2014
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ischemia Reperfusion InjuryStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02540447
Sponsor's protocol ID: Purge_LTX
Acronym: PNP
Status last verified: Dec 2016
First submitted: 30 Aug 2015
Last updated: 26 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury

All Ischemia Reperfusion Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Graft Portal Reperfusion Without Purging Graft Preservative Solution In Living Donor Liver Transplantation. A Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02540447
Acronym / sponsor ID: PNP / Purge_LTX
Conditions: Ischemia Reperfusion Injury
Keywords: Liver transplantation, Graft rinse, Ischemia reperfusion injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: Jan 2013
Primary completion: May 2014 (actual)
Study completion: May 2015 (actual)
First posted: 4 Sep 2015 (estimated)
Results: Posted 20 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Purge	Experimental	Procedure: PurgeThe donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.
No Purge	No intervention	–The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Adult living donor liver transplantation recipients of either sex in mansoura liver transplantation program

Key exclusion criteria (3 listed)

re-transplantation
Previous upper abdominal operation
Budd Chiari syndrome

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
PurgeIn the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping	Procedure or surgery	Purge

Primary outcome

Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure
Time frame: 5 minutes post-reperfusion
The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping

4 secondary outcomes

Biliary Complications (Participants)
Time frame: 3 months
Ischemia Reperfusion Injury
Time frame: 7 days
Post-operative Infectious Complications
Time frame: 30 days
3 Months Mortality
Time frame: 3 Months

Results and safety

Results posted to the registry on 20 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Purge	40	40
No Purge	40	40

Primary outcome: Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure

Time frame: 5 minutes post-reperfusion. Mean (Standard Deviation). Unit: mmHg

Measure	Purge n = 40	No Purge n = 40
Value	66.03 (6.13)	57.75 (5.91)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months complications. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Purge	4 of 40 (10%)	18 of 40 (45%)	Not reported
No Purge	3 of 40 (7.5%)	15 of 40 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Ischemia Reperfusion Injury

Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury

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?

A study testing Purge in people with Ischemia Reperfusion Injury, 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 3 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 26 Apr 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?

Yes. Results are posted in the registry (first posted 20 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure (time frame: 5 minutes post-reperfusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02540447.

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 26 Apr 2017.