Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers

September 24, 2013 updated by: Moahmed Hassan Emara, Zagazig University

Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers

Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Zagazig University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all adult patients with gastroduodenal ulcer

Exclusion Criteria:

  • Patients with non ulcer bleeding.
  • Patients with malignancy.
  • Patients with bleeding disorders or under coagulation therapy.
  • Patients with known allergy to epinephrine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Autologous blood
Patients will be injected by autologous blood at the edge of actively bleeding ulcer
Biological: Blood
5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.
Other: Epinephrine injection
Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer
Drug: Epinephrine
10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl).
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Mohamed H Emara, MD, Tropical Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#:278/12-3-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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