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

March 20, 2012
September 24, 2013
March 2012
September 2013   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01560702 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Comparative Study of Autologous Blood Injection Versus Diluted Epinephrine in Treating Actively Bleeding Gastroduodenal Ulcers
Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers

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

To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Blood, Injection, Injury Type Phobia
  • Gastrointestinal Ulcer Haemorrhage
  • Adverse Reaction to Epinephrine
  • Drug: Epinephrine
    10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an 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    5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.
  • Active Comparator: Autologous blood
    Patients will be injected by autologous blood at the edge of actively bleeding ulcer
    Intervention: Biological: Blood
  • Epinephrine injection
    Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer
    Intervention: Drug: Epinephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01560702
IRB#:278/12-3-2012
Yes
Moahmed Hassan Emara, Zagazig University
Zagazig University
Not Provided
Principal Investigator: Mohamed H Emara, MD Tropical Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt
Zagazig University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP