Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
This study is currently recruiting participants.
Verified April 2013 by Zagazig University
Sponsor:
Zagazig University
Information provided by (Responsible Party):
Moahmed Hassan Emara, Zagazig University
ClinicalTrials.gov Identifier:
NCT01560702
First received: March 20, 2012
Last updated: April 4, 2013
Last verified: April 2013
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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:
Drug Information available for:
Epinephrine bitartrate
Epinephrine
Epinephrine hydrochloride
Racepinephrine hydrochloride
Racepinephrine
U.S. FDA Resources
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: 10 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: 10 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 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5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560702
Contacts
| Contact: Mohamed H Emara, MD | +201002724482 | emara_20007@yahoo.com |
| Contact: Tarik I Zaher, MD | tareqzaher@zu.edu.eg |
Locations
| Egypt | |
| Zagazig University Hospitals | Recruiting |
| Zagazig, Sharkia, Egypt, 44519 | |
| Contact: Mohamed H Emara, MD +201002724482 emara_20007@yahoo.com | |
| Contact: Tarik I Zaher, MD tareqzaher@zu.edu.eg | |
| Principal Investigator: Mohamed H Emara, MD | |
| Principal Investigator: Tarik I Zaher, MD | |
| Sub-Investigator: Ehab M Darwiesh, MD | |
| Sub-Investigator: Ahmed S Bihery, MD | |
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: | April 4, 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 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 Sympathomimetics |
ClinicalTrials.gov processed this record on May 23, 2013