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Completed

NCT Number: NCT02540447

Purge Vs no Purge in Living Donor Liver Transplantation Recipients

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.

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Key information

Conditions

Ischemia Reperfusion Injury Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liver transplantation project - Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • re-transplantation
  • Previous upper abdominal operation
  • Budd Chiari syndrome

Treatment and study plan

Purge

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Biliary Complications (Participants)

    Time frame: 3 months

    Participants who developed biliary complications in three months period (Participant)

  2. Ischemia Reperfusion Injury

    Time frame: 7 days

    incidence of ischemia reperfusion injury in the transplanted graft

  3. Post-operative Infectious Complications

    Time frame: 30 days

  4. 3 Months Mortality

    Time frame: 3 Months

    mortality within first 3 post-operative months

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: PNP

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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