Investigation of Tranexamic-Acid effect on treatment of admitted patients due to upper gastrointestinal bleeding
Design
This study is one-blinded clinical trial. The study population included all patients admitted to the Kermanshah hospital with diagnosis of upper gastrointestinal bleeding. Approximately 70 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study, which will be carried out at Imam Reza hospital in Kermanshah city, is one-blinded , that patients will be blinded to the study groups, the dosage of the drug and the manufacturer of the medicine. At the beginning of the study, the rate and severity of bleeding will be recorded in a checklist
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with diagnosed upper gastrointestinal bleeding
exclusion criteria: Patients with renal failure and subarachnoid hemorrhage;Sensitivity to drug;Bleeding of urinary tract
Intervention groups
The first intervention group will receive the usual treatment of upper gastrointestinal bleeding (fluid therapy and pentoprazole infusion).
The second intervention group will be treated with intravascular injections with a dose of one gram of infusion intravenous stat, and then with one gram Tranexamic-Acid every 8 hours , in addition to the usual treatment (liquid therapy and infusion of pentoprazole).
Main outcome variables
The upper gastrointestinal tract amount of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N92
Registration date:2018-06-06, 1397/03/16
Registration timing:prospective
Last update:2018-06-06, 1397/03/16
Update count:0
Registration date
2018-06-06, 1397/03/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2638-03-23, 2017/01/03
Expected recruitment end date
2639-03-11, 2017/12/20
Actual recruitment start date
2638-05-22, 2017/03/01
Actual recruitment end date
2638-05-22, 2017/03/01
Trial completion date
empty
Scientific title
Investigation of transaxic acid effect on treatment of admitted patients due to upper gastrointestinal bleeding
Public title
The effect of transaxic acid on upper gastrointestinal bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosed upper gastrointestinal bleeding
Exclusion criteria:
Patients with renal failure and subarachnoid hemorrhage
Sensitivity to drug
Bleeding of urinary tract
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Individually randomization method using a random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients were blinded to the dosage of the drug and the manufacturer of the drug in comparison to the study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
ir.kums.rec.1397.004
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
The upper gastrointestinal tract amount of bleeding
Timepoint
During the study
Method of measurement
Using information recorded in the patients file
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive the usual treatment of upper gastrointestinal bleeding (fluid therapy and pentoprazole infusion).
Category
Treatment - Drugs
2
Description
The second intervention group, in addition to the usual treatment (fluid therapy and pentoprazole infusion), will be treated with Tranxamic Acid Monosaccharide (Caspian) Company (Rasht, Iran) with 1 g infusion intravenous stat and then one gram each 8 hours with Transxamic Acid.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Parastar Boulevard
Full name of responsible person
Mehdi Hamzeei
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mehdihz68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehdi Hamzeei
Position
Resident of Internal
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mehdihz68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Homayon Bashiri
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
hbashirimd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mehdi Hamzeei
Position
Resident of Internal
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mehdihz68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail