The aim of study was to evaluate the efficacy of topical tranexamic acid for the treatment of gastrointestinal hemorrhage due to bleeding peptic ulcers. Patients who were known to be less than 18 years of age with the diagnosis of bleeding gastric or duodenal ulcer were studied provided there were no contraindication for endoscopy. One hundred twenty patients were evaluated for gastrointestinal bleeding. A total of 21 patients(10girls,11boys) aged 1 month to 15 years were recruited in the study.
In an interventional study, patients were randomly divided into two groups. In case group tranexamic acid was administered directly on the bleeding ulcer during endoscopy . In control group epinephrine (1/10000) was applied on the ulcer as the standard endoscopic therapy. Both drugs were administered during endoscopy after the patients were hospitalized for the control of GI bleeding.
The rate of re-bleeding, the number of blood transfusions and the duration of hospital stay were compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306105330N6
Registration date:2014-02-24, 1392/12/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-24, 1392/12/05
Registrant information
Name
Mandana Rafeey
Name of organization / entity
Liver and gastrointestinal research center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1331 4135
Email address
rafieem@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-08-30, 1391/06/09
Expected recruitment end date
2013-08-30, 1392/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
TOPICAL TRANEXAMIC ACID AS A NOVELTREATMENT
FOR BLEEDING GASTRIC ULCER
Public title
TOPICAL TRANEXAMIC ACID
FOR GASTRIC ULCER
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Endoscopic diagnose of bleeding duodenal or gastric ulcer; patient age less than 18 years.
Exclusion Criteria: Contraindication for endoscopy; another disease or co-morbidity; coagulopathy; altered post-surgical anatomy of the stomach or duodenum; presence of portosystemic shunt; treatment by other endoscopic or surgical modalities within 14 days prior to the intended application of tranexamicacid(TXA); patients with hemodynamic instability and a drop in hemoglobin(Hb) level more than 2 g/dl in two hours.
Age
To 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
92181
Health conditions studied
1
Description of health condition studied
peptic ulcer
ICD-10 code
k25
ICD-10 code description
Gastric ulcer
Primary outcomes
1
Description
the evidence of clinically recurrent bleeding
Timepoint
within first two days after index endoscopy
Method of measurement
confirmed clinically or by diagnostic upper gastrointestinal endoscopy or surgery
Secondary outcomes
1
Description
the number of blood transfusions and hospital stay duration
Timepoint
during hospitalization
Method of measurement
by clinician
Intervention groups
1
Description
In case group, 4-5 milliliter of tranexamic acid(500mg/5ml vial) was administered directly on the bleeding ulcer .This treatment was used as a single dose during endoscopy .
Category
Treatment - Drugs
2
Description
In control group, 4-5 milliliter of epinephrine (1/10000) was administered directly on the bleeding ulcer .This treatment was used as a single dose during endoscopy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Ali Meshkini
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr Maryam Shoaran
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz children hospital, Sheshgelan St, Tabriz, Iran