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

NCT01560702 | Completed DMC

• 1 other identifier: IRB#:278/12-3-2012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

autologous blood; epinephrine; endoscopy; ulcer; hemostasis

Outcome Measures

Primary Outcomes (1)

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

  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).

  12 months

Study Arms (2)

Autologous blood

ACTIVE COMPARATOR

Patients will be injected by autologous blood at the edge of actively bleeding ulcer

Biological: Blood

Epinephrine injection

OTHER

Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer

Drug: Epinephrine

Interventions

Epinephrine DRUG

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

Epinephrine injection

Blood BIOLOGICAL

5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.

Autologous blood

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• all adult patients with gastroduodenal ulcer

You may not qualify if:

• Patients with non ulcer bleeding.
• Patients with malignancy.
• Patients with bleeding disorders or under coagulation therapy.
• Patients with known allergy to epinephrine.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44519, Egypt

Location

Related Links

• Our Department official journal
• Our Hospital

MeSH Terms

Conditions

Ulcer

Interventions

Epinephrine; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mohamed H Emara, MD

  Tropical Medicine Department, Faculty of Medicine, Zagazig University, Zagazig, 44519, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 25, 2013

Record last verified: 2013-09

Locations

EG (1)