the effect of tranexamic acid on cerebral hemorrhage

Comparing intravenous infusion of Tranexamic Acid to prevent the progression of cerebral hemorrhage in patients with traumatic brain injury with placebo

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015090423890N1

Enrollment

Registered

2015-11-21

Start date

2015-09-23

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

Head injury. traumatic intracerebral haemorrhage , Epidural haemorrhage Extradural haemorrhage (traumatic), Traumatic subdural haemorrhage

Interventions

Intervention 1: Intervention 1: Tranexamic acid 500 mg per 5 ml ampule of Caspian Tamin pharmaceutical company intravenous infusion at a single dose of 1 gr in 8 hours from trauma. Intervention 2: In

Treatment - Drugs

Intervention 1: Tranexamic acid 500 mg per 5 ml ampule of Caspian Tamin pharmaceutical company intravenous infusion at a single dose of 1 gr in 8 hours from trauma

Intervention 2: Intravenous infusion of 10 cc Normal Saline

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria:1) The age above 18 years old 2) The existence of hemorrhage in brain CT scan including subdural hematoma, epidural hematoma ,intra cerebral hemorrhage and intraventricular hemorrhage 3) less than 8 hours passed from trauma 4) The absence of coagulopathy Exclusion criteria: 1) Performing craniotomy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Brain hemorrhage volume. Timepoint: Before intervention and 24 hours after intervention. Method of measurement: Volume in ml of blood in the brain CT scan on the hospital's network. It calculate by multiplying the maximum length in maximum width in number of cuts of hemorrhage in centimeter divided by the 2,and registering on designed form.	—

Secondary

Measure	Time frame
The number of days of hospitalization in the intensive care unit. Timepoint: From admission of the patient until transmitting him/her from the ICU to the ward. Method of measurement: Counting the number of days from entry and exit register in intensive care unite.;Died in the first seven days of hospitalization. Timepoint: Seven days after hospitalization. Method of measurement: Using the registry of death in hospital.	—

Measure

Time frame

The number of days of hospitalization in the intensive care unit. Timepoint: From admission of the patient until transmitting him/her from the ICU to the ward. Method of measurement: Counting the number of days from entry and exit register in intensive care unite.;Died in the first seven days of hospitalization. Timepoint: Seven days after hospitalization. Method of measurement: Using the registry of death in hospital.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Modjallal Najjar

Vice chancellor for research, Shahid Sadoughi University of Medical Sciences

fmojallal@ssu.ac.ir,fmodjallal@yahoo.com+98 358235055

Outcome results

None listed

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