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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01560702
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : September 25, 2013
Information provided by (Responsible Party):
Moahmed Hassan Emara, Zagazig University

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

Condition or disease Intervention/treatment Phase
Blood, Injection, Injury Type Phobia Gastrointestinal Ulcer Haemorrhage Adverse Reaction to Epinephrine Drug: Epinephrine Biological: Blood Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.

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.

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Moahmed Hassan Emara, Lecturer, Zagazig University Identifier: NCT01560702     History of Changes
Other Study ID Numbers: IRB#:278/12-3-2012
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 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