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

NCT ID: NCT01560702

Last Updated: 2013-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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

Conditions

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

Keywords

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endoscopy ulcer hemostasis autologous blood epinephrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous blood

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

Group Type ACTIVE_COMPARATOR

Blood

Intervention Type BIOLOGICAL

5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.

Epinephrine injection

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

Group Type OTHER

Epinephrine

Intervention Type DRUG

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

Interventions

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Epinephrine

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

Intervention Type DRUG

Blood

5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Moahmed Hassan Emara

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed H Emara, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Zagazig University Hospitals

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

Related Links

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http://mis.zu.edu.eg/ajied/home.aspx

Our Department official journal

Other Identifiers

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IRB#:278/12-3-2012

Identifier Type: -

Identifier Source: org_study_id