NCT02534025

Brief Summary

Remote (upper arm) ischemic preconditioning in the donor of living donor liver transplanta to ameliorate the effect of reperfusion injury in recipients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 9, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

August 9, 2015

Last Update Submit

February 5, 2017

Conditions

Liver Transplanatation

Outcome Measures

Primary Outcomes (1)

  • liver enzymes ( SGOT and SGPT) as indicator of graft injury

    Hemodynamic effects of reperfusion ijury

    30 minutes

Study Arms (2)

P group

EXPERIMENTAL

Elevation of Cuff pressure to 200 mm Hg for 5 minutes four times 5 minutes apart

Procedure: Ischemia preconditioining

C group

NO INTERVENTION

no intervention will be added to routine anesthetic mangement

Interventions

Ischemia preconditioiningPROCEDURE

Elavate blood pressure cuff pressure to 200

P group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All candidates for living donor liver transplantation

You may not qualify if:

  • Donors with peripheral vascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Mansurah, Dkahleya, Egypt

RECRUITING

Central Study Contacts

AlRefaey Kandeel, MD

CONTACT

+201008158591refa3ey2@yahoo.com

Amr Yassen, MD

CONTACT

Amryassen@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 9, 2015

First Posted

August 27, 2015

Study Start

January 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

EG(1)