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IRCT2015090423890N1 IRCT 2015-11-21 Vice chancellor for research, Shahid Sadoughi University of Medical Sciences 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 2015-09-23 anticipated 50 Complete https://irct.ir/trial/20306 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A Head injury. 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: Intervention 2: Intravenous infusion of 10 cc Normal Saline.
public Fatemeh Modjallal Najjar
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Sq.
Yazd Iran (Islamic Republic of) ۸۹۱۶۹۷۸۴۷۷ +98 358235055 fmojallal@ssu.ac.ir,fmodjallal@yahoo.com Vice chancellor for research, Shahid Sadoughi University of Medical Sciences scientific Mehdi Bagherabadi
Shahid Sadoughi University of Medical Science, Shahid Bahonar Sq.
Yazd Iran (Islamic Republic of) 89195-741 +98 358261158 Mehdi.bagherabadi@yahoo.com Shahid Sadoughi University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both S06.3 - S0 traumatic intracerebral haemorrhage , Epidural haemorrhage Extradural haemorrhage (traumatic), Traumatic subdural haemorrhage Treatment - Drugs 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 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. 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. Vice chancellor for research, Shahid Sadoughi University of Medical Sciences Approved 2014-10-07 Ethics Committee of Yazd Shahid Sadughi University of Medical Sciences Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Square Yazd Iran (Islamic Republic of)