Albumin Bilirubin Index as a Predictor of Outcome of Vari... | NCT06614114

Studies
Albumin Bilirubin Index as a Predictor of Outcome of Variceal Bleeding

NCT06614114

Sponsor

Assiut University

Status

Recruiting

Last Update Posted

Sep 26, 2024Actual

Enrollment

48Estimated

Phase

Not provided

Conditions

Prediction of Variceal Bleeding

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 24, 2024Estimated

Primary Completion Date

Apr 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Sep 9, 2024

First Submission Date that Met QC Criteria

Sep 24, 2024

First Posted Date

Sep 26, 2024Actual

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

Sep 24, 2024

Last Update Posted Date

Sep 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Albumin bilirubin index as a predictor of outcome of variceal bleeding

Detailed Description

This study is to clarify the predictive value of albumin bilirubin index for recurrent bleeding within 3 month after endoscopic treatment in patients with cirrhosis and EGVB

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevelence of Variceal bleeding in high alb/bill index	Prevelence of bleeding in patient with cirrhosis	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 18-80 years old

Exclusion Criteria:

Hcc Hematological disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

All patients had developed variceal bleed and who had been admitted via emergency

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heba Sayed Zaki	Contact	0201148259100		hoopa.1996@gmail.com
Ahmed M.Ashmawy	Contact	01005679880		dr.Ashmawy82@gmail.com

Overall Officials

Name	Affiliation	Role
Heba Sayed Zaki	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university hospital	Recruiting	Asyut		Assiut	Egypt