The purpose of this study was to investigate the effect of tranexamic acid in traumatic injuries in order to have its effect on reducing the need for blood transfusion or its products, mortality and reduction of hospitalization in intensive care unit.
Design
This study was a parallel randomized controlled clinical trial study design. The sample size of the study is 330 traumatic patients that will be assigned to intervention and control groups using block randomization method.
Settings and conduct
To reduce blood transfusion and its products in traumatic patients who needed, tranexamic acid will be prescribed by the prehospital emergency in the scene and infusion dose will be performed at Rasoul Akram and Shohadaye Haftom -e-Tir Hospitals of Iran University of Medical Sciences. To evaluate the effect of tranexamic acid on blood transfusion, mortality and length of stay in intensive care unit for up to 24 hours after admission. Study participants, physicians that assessing the outcomes and Data analyzer will be blind to the type of interventions that patients received.
Participants/Inclusion and exclusion criteria
Traumatic patients in the age range of 14-50 years with a COAST score above two will be included in the study. In addition, more than three hours after the accident are the main exclusion criteria.
Intervention groups
The intervention group will be received tranexamic acid in the initial dose of one gram of 50 milliliter normal saline within 10 minutes (once only), along with other prehospital treatment processes. In this group, the maintenance dose infusion of one gram per 100 milliliter will continue in the hospital for eight hours (up to 24 hours in three stages). The control group will not be used it and only the therapeutic processes required for patients will be performed.
Main outcome variables
Blood transfusion or products, mortality, length of stay in intensive care unit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140528017891N7
Registration date:2019-11-24, 1398/09/03
Registration timing:registered_while_recruiting
Last update:2019-11-24, 1398/09/03
Update count:0
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Nader Tavakoli
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8891 5410
Email address
tavakoli.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-16, 1398/08/25
Expected recruitment end date
2020-12-30, 1399/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of effectiveness prehospital received tranexamic acid on transmission blood volume on severe trauma patients
Public title
Tranexamic acid effect on blood volume transmission
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 14-50
Having COAST score more than 2
Bring up to hospital by Tehran emergency medical service
Exclusion criteria:
Passing 3 hours from trauma
Having signs of Disseminated intravascular coagulation, myocardial infarction, pulmonary embolism, Stroke Warning Signs and Symptoms
Allergic reaction
Age
From 14 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
330
Randomization (investigator's opinion)
Randomized
Randomization description
For prevention of selection bios in participants into study groups,we use the randomization methods.Ranom Alloction software will be used for randomization process.Participants will be randomized with blocked randomizationmethod(with random blocks) to recieve drug(inervention).The output of allocation will be specified with A and B for being blind to the research team. In this process,allocated participants in accordance with basic blocks are not predictable.
Blinding (investigator's opinion)
Triple blinded
Blinding description
We will inform the supervisor after selecting each patient.Blinding process in this study is triple blinded. They are selected on the randomized output and Its adaption to the participant's number.Blinding process in this study is triple blinded.The intervention will be sent in a form that is not known to the patient statistical analysor and evaluator of the outcomes to decrease the rate of information bios in intervention and outcome valiables.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of Medical Sciences
Street address
بزرگراه همت، دانشگاه علوم پزشکی ایران
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-08-17, 1398/05/26
Ethics committee reference number
IR.IUMS.REC.1398.477
Health conditions studied
1
Description of health condition studied
Bleeding in trauma
ICD-10 code
T14.5
ICD-10 code description
Injury of blood vessel(s) of unspecified body region
Primary outcomes
1
Description
Bleeding control
Timepoint
Up to 24 hours after admission to hospital
Method of measurement
Get blood products
2
Description
Mortality
Timepoint
Up to 24 hours after admission to hospital
Method of measurement
Vital signs observation in patient
Secondary outcomes
1
Description
Length time in intensive care unit
Timepoint
The number of days the patient is in intensive care
Method of measurement
Counting the days when the patient was in the ward
Intervention groups
1
Description
Intervention group: They will receive tranexamic acid at an initial dose of one gram of 50 milliliter normal saline within 10 minutes (only once), along with other prehospital treatment processes. In addition, the infusion of a maintenance dose of 1 germ per 100 milliliter will continue in the hospital for eight hours (up to 24 hours in three stages).
Category
Treatment - Drugs
2
Description
Control group: In this group placebo will not be used and only the treatment processes required for the patients will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Nader Tavakoli
Street address
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 9260
Fax
+98 21 6653 9233
Email
tavakoli.n@iums.ac.ir
2
Recruitment center
Name of recruitment center
Shohadaye Haftom -e-Tir
Full name of responsible person
Nader Tavakoli
Street address
South Shahid Rajaee Highway
City
Tehran
Province
Tehran
Postal code
1886718136
Phone
+98 21 6653 9260
Fax
+98 21 6653 9233
Email
tavakoli.n@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
empty
Title of funding source
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Tehran Emergency Center
Full name of responsible person
Peyman Saberian
Street address
No. 58, Tehran Emergency Center, Sharif Alley, South Iranshahr Ave.
City
Tehran
Province
Tehran
Postal code
1581615117
Phone
+98 21 4923 1000
Fax
+98 21 4923 1000
Email
research@tehran115.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Emergency Center
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nader Tavakoli
Position
Association
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
خیابان ستارخان، خیابان نیایش، بیمارستان رسول اکرم
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 9260
Fax
+98 21 6653 9233
Email
Tavakoli.n@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nader Tavakoli
Position
Association
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Rasoul Akram Hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 9260
Fax
+98 21 6653 9233
Email
Tavakoli.n@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nader Tavakoli
Position
Association
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Rasoul Akram Hospital, Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 9260
Fax
+98 21 6653 9233
Email
tavakoli.n@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Findings of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables.
When the data will become available and for how long
Availability eight months after the end of study
To whom data/document is available
Specialists of emergency medicine and prehospital emergency
Under which criteria data/document could be used
In the case of comparison with other similar trials or treatmen
From where data/document is obtainable
Iran University of Medical Sciences and Tehran emergency center
What processes are involved for a request to access data/document
By referring to the central library and clinical trial center in Iran University of Medical Sciences can access to the documents of participants, data and results.