Remote Ischemic Preconditioning in Liver Transplantation | NCT02534025

Studies
Remote Ischemic Preconditioning in Liver Transplantation

NCT02534025

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Feb 7, 2017Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Liver Transplanatation

Interventions

Ischemia preconditioining

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Feb 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Aug 9, 2015

First Submission Date that Met QC Criteria

Aug 26, 2015

First Posted Date

Aug 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Upper arm ischemia will be induced by elevation of NIBP cuff pressure to 200 mm Hg for 5 minutes repeated four times 5 mniutes apart, aiming to decrease the effect of ischemia reperfusion in the graft liver.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ischemia preconditioining	Procedure	Elavate blood pressure cuff pressure to 200	P group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
liver enzymes ( SGOT and SGPT) as indicator of graft injury	Hemodynamic effects of reperfusion ijury	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All candidates for living donor liver transplantation

Exclusion Criteria:

Donors with peripheral vascular disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AlRefaey Kandeel, MD	Contact	+201008158591		refa3ey2@yahoo.com
Amr Yassen, MD	Contact			Amryassen@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura university	Recruiting	Al Mansurah	Dkahleya		Egypt