Tranexamic Acid is used in a wide range of haemorrhagic conditions. The drug may reduce all-cause mortality in gastrointestinal bleeding but there are some reports about complications of systemic TA administration. However, topical TA was found effective in controlling bleeding in patients with hemorrhagic diathesis and to our knowledge there is no report of its topical use in UGIB. The goal of the current study was to determine the efficacy of a single dose of TA, administered topically, on bleeding from the benign peptic lesions. All patients with symptoms or signs of GI bleeding who will refer to Hazrat Rasool Emergency Department will be assessed. This is a double blind randomized controlled clinical trial study. Participants will undergo endoscopy within 24 hours of admission and each patient with UGIB due to benign peptic lesions will be enrolled. We compare the amount of Packed RBCs, rebleeding episodes, 30-day mortality and probable complication (thrombosis) between intervention and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201148721N1
Registration date:2012-11-06, 1391/08/16
Registration timing:na
Last update:
Update count:0
Registration date
2012-11-06, 1391/08/16
Registrant information
Name
Mahdi Rezai
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 1103
Email address
rezaei-m@razi.tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Private Resources (Attending physician and resident)
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of topical Tranexamic Acid on management of acute upper gastrointestinal bleeding in patients presented to emergency department
Public title
Effect of topical Tranexamic Acid on management of gastrointestinal bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Symptoms or signs of GI bleeding. Exclusion Criteria: Pregnancy; Lactation; Gastrointestinal Malignancy; Coagulopathy; History of Thromboembolism; History of myocardial infarction or ischemic cerebrovascular accident; End Stage Renal Disease; Allergy to TA; Undergoing anticoagulation therapy; Congenital or acquired coagulopathy; who were reluctant to enroll in this study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Jalalieh St., Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-05-07, 1391/02/18
Ethics committee reference number
90 / د / 130 / 2781
Health conditions studied
1
Description of health condition studied
Upper Gastrointestinal Bleeding
ICD-10 code
K29.0
ICD-10 code description
Acute haemorrhagic gastritis
Primary outcomes
1
Description
Packed RBC
Timepoint
from intervention to discharge
Method of measurement
patient hospital document
Secondary outcomes
1
Description
30-day Mortality
Timepoint
From intervantion to 1 month later
Method of measurement
Patients' Hospital Document and Phone Contact
2
Description
Tranexamic Acid Complication
Timepoint
during the study
Method of measurement
According to clinical manifestation, physical examination and doppler sonography
3
Description
Re-bleeding
Timepoint
From intervention to Discharge
Method of measurement
Patients' Hospital Document
Intervention groups
1
Description
Interventio group: In addition to conventional therapy, we add 1 gram tranexamic acid, diluted into 500cc normal saline, to gastric washing fluid. we used Tranexamic Acid Ampule manifactured by Caspian compancy in Rasht, Iran.
Category
Treatment - Drugs
2
Description
Control group: In addition to conventional therapy, we add free water (similar to tranexamic acid ampule) to fliud water for gastric washing.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Mahdi Rezai
Street address
Hazrat Rasool hospital, Niayesh St., Sattarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private Resiurces (Attending and Resident of incharge)
Full name of responsible person
Mahdi Rezai
Street address
Emergency Department of Hazrat Rasool Hospital, Niayesh St., Sattarkhan St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private Resiurces (Attending and Resident of incharge)
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
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Rezai
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Hazrat Rasool hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 8868 1103
Fax
Email
rezaei-m@razi.tums.ac.ir ; mah_re@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Rezai
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Hazrat Rasool hospital, Tehran
City
Tehran
Postal code
Phone
+98 21 8868 1103
Fax
Email
rezaei-m@razi.tums.ac.irmah_re@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahdi Rezai
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Hazrat Rasool Hospital
City
Tehran
Postal code
Phone
+98 21 8868 1103
Fax
Email
rezaei-m@razi.tums.ac.irmah_re@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)