Causes of Disqualification of Egyptian Potential Living L... | NCT01809249

Studies
Causes of Disqualification of Egyptian Potential Living Liver Donors

NCT01809249

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Mar 12, 2013Estimated

Enrollment

192Actual

Phase

Not provided

Conditions

Donors Safety

Interventions

Not provided

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

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 9, 2013

First Submission Date that Met QC Criteria

Mar 9, 2013

First Posted Date

Mar 12, 2013Estimated

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

Mar 9, 2013

Last Update Posted Date

Mar 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Due to absence of Deceased-donors in Egypt, Living-donor liver transplantation (LDLT) has emerged as an option to the traditional deceased-donor transplantation procedure. But there is an essential risk related to liver resection for healthy donors.

Detailed Description

The aim of this work is to identify and analyze the causes of disqualification of potential Egyptian living liver-donors in a University based liver transplant program

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

192Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
causes of disqualification of potential Egyptian living liver-donors		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All potential living liver donors in the period from June 2010 to June 2012
1. Age between 18 and 50 years
2. Relationship within 3rd degree of consanguinity with recipient or spouse.
3. The donor-recipient pair must be blood group compatible.
4. An informed consent should be obtained.

Exclusion Criteria:

Patients with nknown mrsdical or surgical history that interfere with donation
- Underlying medical condition (diabetes, cardiopulmonary disease, etc.).
- ABO incompatibility

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

potential living liver donors

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams Center For Organ Transplantation (ASCOT),Ain Shams university		Cairo			Egypt