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

Not Applicable

Completed

• Conditions: Blood, Injection, Injury Type Phobia; Gastrointestinal Ulcer Haemorrhage; Adverse Reaction to Epinephrine
• Interventions: Biological: Blood; Drug: Epinephrine

• Registration Number: NCT01560702
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous blood	Blood	Patients will be injected by autologous blood at the edge of actively bleeding ulcer
Epinephrine injection	Epinephrine	Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer

Primary Outcome Measures

Name	Time	Method
hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Sharkia, Egypt