NCT02540447

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

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

January 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 20, 2015

Completed
Last Updated

April 26, 2017

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

August 30, 2015

Results QC Date

September 5, 2015

Last Update Submit

March 24, 2017

Conditions

Ischemia Reperfusion Injury

Keywords

Liver transplantationGraft rinseIschemia reperfusion injury

Outcome Measures

Primary Outcomes (1)

  • 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

    5 minutes post-reperfusion

Secondary Outcomes (4)

  • Biliary Complications (Participants)

    3 months

  • Ischemia Reperfusion Injury

    7 days

  • Post-operative Infectious Complications

    30 days

  • 3 Months Mortality

    3 Months

Study Arms (2)

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.

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.

Interventions

PurgePROCEDURE

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

Purge

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver transplantation project - Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Amr Mohamed Yassen Ali Badawy
Organization
Mansoura Faculty of Medicine
amryassen@hotmail.com
+201001497044

Study Officials

  • Amr M Yassen, MD

    Mansoura Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia and Intensive Care

Study Record Dates

First Submitted

August 30, 2015

First Posted

September 4, 2015

Study Start

January 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2015

Last Updated

April 26, 2017

Results First Posted

October 20, 2015

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)