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

Blood, Injection, Injury Type Phobia Clinical Trial

Official title:

Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560702
• Other study ID #: IRB#:278/12-3-2012
• Status: Completed
• Phase: N/A
• First received: March 20, 2012
• Last updated: September 24, 2013
• Start date: March 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Zagazig University
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Reaction to Epinephrine
• Blood, Injection, Injury Type Phobia
• Gastrointestinal Ulcer Haemorrhage
• Peptic Ulcer
• Ulcer

Intervention

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5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.		12 months	Yes
Secondary	development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl).		12 months	Yes

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