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

This study has been completed.
Information provided by (Responsible Party):
Moahmed Hassan Emara, Zagazig University Identifier:
First received: March 20, 2012
Last updated: September 24, 2013
Last verified: September 2013
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.

Condition Intervention
Blood, Injection, Injury Type Phobia Gastrointestinal Ulcer Haemorrhage Adverse Reaction to Epinephrine Drug: Epinephrine Biological: Blood

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers

Resource links provided by NLM:

Further study details as provided by Moahmed Hassan Emara, Zagazig University:

Primary Outcome Measures:
  • hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: March 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.
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.

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.

Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01560702

Zagazig University Hospitals
Zagazig, Sharkia, Egypt, 44519
Sponsors and Collaborators
Zagazig University
Principal Investigator: Mohamed H Emara, MD Tropical Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt
  More Information

Additional Information:
Responsible Party: Moahmed Hassan Emara, Lecturer, Zagazig University Identifier: NCT01560702     History of Changes
Other Study ID Numbers: IRB#:278/12-3-2012
Study First Received: March 20, 2012
Last Updated: September 24, 2013

Keywords provided by Moahmed Hassan Emara, Zagazig University:
autologous blood

Additional relevant MeSH terms:
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on September 19, 2017