NCT02405286

Brief Summary

This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

March 24, 2015

Last Update Submit

March 31, 2015

Conditions

Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

  • Clinical condition of the patients with accute upper gastrointstinal bleeding after 48 hours from endoscopy

    48 hours

Secondary Outcomes (1)

  • number of participants with variceal bleeding and other causes of upper gastrointestinal bleeding regarding the clinical condition after 48 hours

    48 hours

Study Arms (1)

Upeer gastrointestinal bleeding

* Adult Egyptian patients. * Patients with acute upper G.I hemorrhage. * Informed consent.

Other: Upper gastrointestinal endoscopy

Interventions

Upper gastrointestinal endoscopyOTHER

Upper gastrointestinal endoscopy, if stigmata of recent hemorrhage are seen, varices are either injected with ethanolamine or banded, depending on the clinical setting and availability .

Upeer gastrointestinal bleeding

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Egyptian patients with acute upper gastrointestinal bleeding

You may qualify if:

  • Adult Egyptian patients.
  • Patients with acute upper G.I hemorrhage.
  • Informed consent.

You may not qualify if:

  • Refuse to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egypt Ain Shams center University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of tropical medicine , Ain Shams university

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 1, 2015

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

EG(1)