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The effect of Tranexamic Acid on prevention of increased hemorrhage in Traumatic Brain Injury

The effect of Tranexamic Acid on prevention of increased hemorrhage in Traumatic Brain Injury

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201011202854N6
Enrollment
150
Registered
2013-02-05
Start date
2013-04-04
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain trauma. Intracranial injury

Interventions

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 interventio
Treatment - Drugs
Administration of Tranexamic acid 1 gr in 100 ml serum as loading dose and then 1 gr in 1000 ml serum during 8 hours
Administration of Normal Salin same as intervention group

Sponsors

Vice chancellor for research, Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hemorrhagic Mass size. Timepoint: Before and 24 hours after drug administration. Method of measurement: Using CT scan.;The effect of mass on brain tissue. Timepoint: Before and 24 hours after drug administration. Method of measurement: Using CT scan.;Adverse effect of tranexamic acid. Timepoint: During drug administration till one week. Method of measurement: Observation and patient examination.

Secondary

MeasureTime frame
Patient recovery status. Timepoint: 3 months after patient discharge. Method of measurement: Based on GCOS.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoumeh Abedzadeh Kalahroudi

Kashan University of Medical Sciences

abedzadeh@kaums.ac.ir+98 36 1562 0634

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026