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Completed

NCT Number: NCT01560702

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.

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Key information

Conditions

Blood, Injection, Injury Type Phobia Adverse Reaction to Epinephrine Gastrointestinal Ulcer Haemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University Hospitals

Zagazig, Sharqia Province, 44519, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epinephrine

Drug

10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.

Blood

Biological

5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.

Primary outcomes

  1. hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.

    Time frame: 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 22, 2012
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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