Objective: To define effect of Tranexamic Acid on reducing the mortality rate and blood transfusion requirements in trauma patients with significant bleeding.
Design: Randomized, double-blind, placebo-controlled trial.
Setting and conduct: 60 traumatic patients meeting inclusion and exclusion criteria were selected and randomly assigned into two groups. For the intervention group, 1000 mg Tranexamic Acid in 100 ml of normal saline was infused in 10 minutes in the first 8 hours of trauma occurrence then 1 gr was infused every 8 hours. control group received normal saline with distilled water. Results were compared between groups.
Inclusion criteria wereage>5 years; Systolic blood pressure<90 mmHg; Heart rate>110; no indication for surgery.
Interventions: intervention and control groups received Tranexamic acid and placebo respectively.
The main outcome variables:Primary outcomes are the rate of mortality and need for blood transfusions were primary outcomes and hospitalization days in intensive care unit, organ failure and the incidence of thromboembolic complications were secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040816473N6
Registration date:2016-05-29, 1395/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Farzad Kakaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fkakaei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
tabriz university of medical science
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tranexamic acid in reducing mortality and the need for blood transfusion in trauma patients with significant bleeding
Public title
The effect of tranexamic acid in reducing mortality and the need for blood transfusion in trauma patients with significant bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age>5 years; Systolic blood pressure<90 mmHg; Heart rate>110; no indication for surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics Committee of Tabriz university of medical science
Street address
Golgasht St, Azadi St
City
Tabriz
Postal code
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
TBZMED.REC.1394.492
Health conditions studied
1
Description of health condition studied
Tranexamic acid
ICD-10 code
Y44.3
ICD-10 code description
Anticoagulant antagonists, vitamin K and other coagulants
2
Description of health condition studied
transfusion
ICD-10 code
Z51.3
ICD-10 code description
Blood transfusion (without reported diagnosis)
Primary outcomes
1
Description
Mortallity
Timepoint
From admission until discharge or death, and a maximum of one month after hospitalization
Method of measurement
via clinical records
2
Description
Need for blood transfusion
Timepoint
From admission until discharge or death, and a maximum of one month after hospitalization
Method of measurement
via clinical records
Secondary outcomes
1
Description
Hospitalization days in ICU
Timepoint
From admission until discharge or death, and a maximum of one month after hospitalization
Method of measurement
via clinical records
2
Description
Organ Failure
Timepoint
From admission until discharge or death, and a maximum of one month after hospitalization
Method of measurement
via clinical records
3
Description
Thrombotic complications
Timepoint
From admission until discharge or death, and a maximum of one month after hospitalization
Method of measurement
via clinical records
Intervention groups
1
Description
In case group: Tranexamic acid infusion
Category
Treatment - Drugs
2
Description
In control group: placebo infusion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Education, Treatment and Research Center
Full name of responsible person
Farzad Kakaei
Street address
Golgasht St, Azadi St
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Science, Golgasht St, Azadi St
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Farzad Kakaei
Position
General Surgeon/ Associate Professor
Other areas of specialty/work
Street address
Imam Reza Education, Treatment and Research Centerl, Golgasht St, Azadi St
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
fkakaei@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
General Surgeon
Other areas of specialty/work
Street address
Imam Reza Education, Treatment and Research Center, Golgasht St, Azadi St
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
fkakaei@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
General Surgeon/ Associate Professor
Other areas of specialty/work
Street address
Imam Reza Education, Treatment and Research Centerl, Golgasht St, Azadi St
City
Tabriz
Postal code
Phone
+98 41 3334 1317
Fax
Email
fkakaei@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)