Determining the rate of mortality in patients with early administration of tranexamic acid
Determining the rate of hemoglobin decrease in patients with early administration of tranexamic acid
Determining the rate of blood transfusion in patients with early administration of tranexamic acid
Determining the rate of mortality in control group of patients
Determining the rate of hemoglobin decrease in control group of patients
Determining the rate of blood transfusion in control group of patients
Comparison of death rate in patients with early administration of tranexamic acid and control group
Comparison of hemoglobin decrease in patients with early administration of tranexamic acid and control group
Comparison of blood transfusion in patients with early administration of tranexamic acid and control group
Design
Clinical trail with control group,blinded,randomised,phase 3 on 66 patients.
Settings and conduct
Multiple trauma patients admitted in emergency department of Ayatollah Mousavi hospital with ABC trauma score more than 2 will divided randomized in 2 groups.1gr Tranexamic acid will be infused in 10minutes to intervention group and Normal Slain will be infused in Control Group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Referred to Ayatollah Mousavi Hospital in Zanjan due to trauma in 1400
- Gender of men and women
- Age over 15 years
- More than 2 points in the ABC scoring system
Exclusion criteria:
- Pregnancy
- Renal failure
- Coagulopathy
- Acute brain injuries
- Consumption of anticoagulants
Intervention groups
Traumatic patients will be divided in two groups of receiving Tranexamic Acid containing serum and Normal Saline as placebo.
Main outcome variables
Comparison of mortality, hemoglobin decrease and blood transfusion in intervention and control groups of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220507054758N1
Registration date:2022-05-24, 1401/03/03
Registration timing:prospective
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Amin Esfandyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3443 2869
Email address
aminesf1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation safety and efficiency of early administration of Tranexamic acid in trauma patient
Public title
Evaluation safety and efficiency of early administration of Tranexamic acid in trauma patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients admitted with multiple trauma over than 15 years old with ABC trauma score more than 2 scores
patient satisfaction to study
Exclusion criteria:
pregnancy
brain injuries
coaglopathy
renal failure
using anticoaglants
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Control group patients will receive normal saline serum which shape and injection is the same as the drug(tranexamic acid).
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Ayatollam Mousavi hosp. Gavazang Blvd. Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2022-10-30, 1401/08/08
Ethics committee reference number
IR.ZUMS.REC.1401.044
Health conditions studied
1
Description of health condition studied
Trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mortality
Timepoint
All days of hospital admission
Method of measurement
Discharge or death of patient
2
Description
Hemoglobin decrease
Timepoint
All days of hospital admission
Method of measurement
Hemoglobin in laboratory data
3
Description
Blood transfusion
Timepoint
All days of hospital admission
Method of measurement
Evaluate patient records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who receive 1 gram Tranexamic Acid during 10 minutes intravenous infusion
Category
Treatment - Drugs
2
Description
Control group: Patients who receive intravenous infusion of Normal Saline during 10 minutes with the same volume of Tranexamic Acid containing serum in intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Ayatollah Mousavi Hospital
Full name of responsible person
Amin Esfandyari Kalajahi
Street address
Ayatollah Mousavi Hospital. Gavazang blvd. Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Web page address
https://mousavi.zums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ali Ammari
Street address
Ayatollah Mousavi hospital. Gavazang blvd. Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Web page address
https://mousavi.zums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan Ayatollah Mousavi hospital
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
Zanjan University of Medical Sciences
Full name of responsible person
Amin Esfandyari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kavazang s. Ayatollah mousavi hosp.
City
زنجان
Province
Zanjan
Postal code
4513956183
Phone
+98 41 3443 2869
Fax
Email
Aminesf1369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Amin Esfandyari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kavazang s. Ayatollah mousavi hosp.
City
زنجان
Province
Zanjan
Postal code
4513956183
Phone
+98 41 3443 2869
Fax
Email
Aminesf1369@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Amin Esfandyari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Kavazang s. Ayatollah mousavi hosp.
City
زنجان
Province
Zanjan
Postal code
4513956183
Phone
+98 41 3443 2869
Fax
Email
Aminesf1369@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
No - There is not a plan to make this available
Title and more details about the data/document
Mechanism of trauma, death or discharge, Hemoglobin changes, blood transfusion
When the data will become available and for how long
1 year after publish
To whom data/document is available
Researchers of academic institutions
Under which criteria data/document could be used
All data on the condition that personal information of patients must be preserved and the person in charge of this project mentioned in the study.
From where data/document is obtainable
Email to Amin Esfandyari Kalajahi, Aminesf1369@gmail.com
What processes are involved for a request to access data/document
After sending the proposal of study and to guarantee that the person in charge of this project mentioned in the study.