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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Epinephrine

Blood

About this trial

This is an interventional treatment trial for Blood, Injection, Injury Type Phobia focused on measuring autologous blood, epinephrine, endoscopy, ulcer, hemostasis

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zagazig University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Autologous blood

Epinephrine injection

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl).

Full Information

NCT ID

NCT01560702

First Posted

March 20, 2012

Last Updated

September 24, 2013

Sponsor

Zagazig University

1. Study Identification

Unique Protocol Identification Number

NCT01560702

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zagazig University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

autologous blood, epinephrine, endoscopy, ulcer, hemostasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous blood

Arm Type

Active Comparator

Arm Description

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

Arm Title

Epinephrine injection

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Epinephrine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Blood

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed H Emara, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zagazig University Hospitals

City

Zagazig

State/Province

Sharkia

ZIP/Postal Code

44519

Country

Egypt

12. IPD Sharing Statement

Links:

URL

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

Description

Our Department official journal

URL

http://www.zu.edu.eg/

Description

Our home institution

Learn more about this trial

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

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