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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201011202854N6 |
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Date of registration:
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2013-02-05 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of Tranexamic Acid on prevention of increased hemorrhage in Traumatic Brain Injury
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Scientific title:
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The effect of Tranexamic Acid on prevention of increased hemorrhage in Traumatic Brain Injury |
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Date of first enrolment:
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2013-04-04 |
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Target sample size:
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150 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/2721 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Masoumeh Abedzadeh Kalahroudi
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Address:
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Kashan University of Medical Sciences,Trauma Research Center, Ravand Road
8715973447
Kashan
Iran (Islamic Republic of) |
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Telephone:
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+98 36 1562 0634 |
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Email:
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abedzadeh@kaums.ac.ir |
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Affiliation:
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Kashan University of Medical Sciences |
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Name:
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Dr. Esmaiel Fakharian
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Address:
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Kashan University of Medical Sciences,Trauma Research center, Ravand Road
8715973447
Kashan
Iran (Islamic Republic of) |
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Telephone:
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+98 36 1562 0634 |
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Email:
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fakharian-e@Kaums.ac.ir |
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Affiliation:
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Kashan University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: Any traumatic brain lesion in CT scan such as sub arachnid hemorrhage, intra Cranial hemorrhage, subdural hemorrhage …; age 15 years and more; non penetrating trauma; the first CT scan within 8 hours after trauma; no need to brain surgery during 8 hours.
Exclusion criteria: patients with coagolopathy; serum creatinine more than 2 mg; massive organs injury; hospital admission after 8 hours from trauma; pregnant patients; drugs which induced coaglopathy; patients who are unable to perform secondary CT scan.
Exclusion criteria:
Age minimum:
15 years
Age maximum:
70 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Brain trauma.
Intracranial injury
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Intracranial injury
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Intervention(s)
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Administration of Tranexamic acid 1 gr in 100 ml serum as loading dose and then 1 gr in 1000 ml serum during 8 hours
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Administration of Normal Salin same as intervention group
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Intervention 1: Administration of Tranexamic acid 1 gr in 100 ml serum as loading dose and then 1 gr in 1000 ml serum during 8 hours. Intervention 2: Administration of Normal Salin same as intervention group.
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Treatment - Drugs
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Primary Outcome(s)
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Hemorrhagic Mass size. Timepoint: Before and 24 hours after drug administration. Method of measurement: Using CT scan.
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Adverse effect of tranexamic acid. Timepoint: During drug administration till one week. Method of measurement: Observation and patient examination.
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The effect of mass on brain tissue. Timepoint: Before and 24 hours after drug administration. Method of measurement: Using CT scan.
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Secondary Outcome(s)
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Patient recovery status. Timepoint: 3 months after patient discharge. Method of measurement: Based on GCOS.
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Source(s) of Monetary Support
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Vice chancellor for research, Kashan University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethical committee of Kashan University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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