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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Moahmed Hassan Emara, Zagazig University
ClinicalTrials.gov Identifier:
NCT01560702
First received: March 20, 2012
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.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

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01560702

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

Additional Information:
No publications provided

Responsible Party: Moahmed Hassan Emara, Lecturer, Zagazig University
ClinicalTrials.gov 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
Health Authority: Egypt: Zagazig University

Keywords provided by Zagazig University:
autologous blood
epinephrine
endoscopy
ulcer
hemostasis

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Ulcer
Phobic Disorders
Wounds and Injuries
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anxiety Disorders
Mental Disorders
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on July 26, 2014