Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.
Blood, Injection, Injury Type Phobia
Gastrointestinal Ulcer Haemorrhage
Adverse Reaction to Epinephrine
|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|
- 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 ]
- 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 ]
|Study Start Date:||March 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Autologous blood
Patients will be injected by autologous blood at the edge of actively bleeding ulcer
5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.
Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer
10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.
To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560702
|Zagazig University Hospitals|
|Zagazig, Sharkia, Egypt, 44519|
|Principal Investigator:||Mohamed H Emara, MD||Tropical Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt|