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

Zagazig University100 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Blood, Injection, Injury Type Phobia Gastrointestinal Ulcer Haemorrhage Adverse Reaction to Epinephrine

Interventions

EpinephrineDRUG

10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.

BloodBIOLOGICAL

5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.

Time frame: 12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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