Intermittent Portal and Graft Purge in Living Donor Liver Transplantation

NCT ID: NCT02845154

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-11-30

Brief Summary

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Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known complication in liver transplantation. Several trials investigated variables that my contribute to the generation of these two complications for reducing their incidence and magnitude. The investigators will investigate the effect of acute conditioning of the recipients circulation to the vasoactive mediators in the graft as well as the congested intestine through intermittent purging of graft contents into the patient's systemic circulation in living donor liver transplantation.

Detailed Description

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Patients are subjected to living donor liver transplantation. In this type of grafts, cold ischemia time is minimal and the graft contents of preservative solution are less than cadaveric grafts. The investigators in the current research use HTC as a preservative solution. These factors justified the possibility of purging the graft and portal blood contents into the patient systemic circulation. The exposure to these fluids in this trial will be in an intermittent manner: the portal vein will be declamped for 5 seconds followed by 30 seconds of portal clamping. This will be repeated twice. The primary outcome objective in this trial will be the incidence of post-reperfusion syndrome. Secondary objectives include the severity of PRS, the incidence and severity of ischemia-reperfusion injury, graft and patient's survival.

Conditions

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Hypotension Ischemia Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control (bolus purge)

The portal vein clamp will be totally released after end of portal vein anastomosis and all graft and portal blood contents are allowed free and complete access to the systemic circulation via the inferior vena cave

Group Type ACTIVE_COMPARATOR

bolus purge

Intervention Type OTHER

complete and uninterrupted purge

Intermittent Purge

The portal clamp will be released in situ for 5 seconds to allow purge of the graft and portal contents into the systemic circulation, followed by 30 seconds of portal clamping again. This will be followed by another two cycles of 5 seconds declamping and 30 seconds clamping , then, the portal clamp will be completely released.

Group Type EXPERIMENTAL

Intermittent purge

Intervention Type OTHER

intermittent portal purge

Interventions

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bolus purge

complete and uninterrupted purge

Intervention Type OTHER

Intermittent purge

intermittent portal purge

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* living donor liver transplantation recipients

Exclusion Criteria

* Non
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Amr Mohamed Yassen

Professor of Anesthesia and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr M Yassen, MD

Role: STUDY_DIRECTOR

Mansoura Faculty of Medicine

Locations

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Liver transplantation program - Gastroenterology surgical center

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Liver transplantation project - Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Gastroenterology surgical center - Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr M Yassen, MD

Role: CONTACT

+201001497044

Adel A Hassan, MD

Role: CONTACT

+201007921234

Facility Contacts

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Amr M Yassen, MD

Role: primary

+201001497044

Waleed R alsarraf, MD

Role: backup

+201222322727

Amr M Yassen, MD

Role: primary

+201001497044

Waleed R Elsarraf, MD

Role: backup

+201222322727

Amr M Yassen, MD

Role: primary

+201001497044

Other Identifiers

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LDLDPURGE

Identifier Type: -

Identifier Source: org_study_id

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