Evaluating the effect of Tranexamic Acid on the Prognosis of Patients with Intracerebral Hemorrhage

Determining the Effect of Tranexamic Acid on the Prognosis of Patients with Intracerebral Hemorrhage Presenting to Imam Khomeini Hospital, Urmia.

This is a prospective, open-label, randomized clinical trial (RCT) with parallel groups, phase 2, on 50 patients. Patients will be randomly assigned into two equal groups (25 patients each) using a computer-generated random number table.

In the intervention group, patients will receive standard treatment (blood pressure control, head elevation, normal saline, blood glucose control, subcutaneous heparin, anticonvulsants, acetaminophen, mannitol) along with tranexamic acid (Raha Pharmaceutical) at a weight-adjusted dose: 15–20 mg/kg IV bolus over 10 minutes, followed by 15 mg/kg IV infusion over 8 hours. The control group will receive only standard treatments without tranexamic acid.

inclusion criteria : Age 18 years and older Confirmation of spontaneous intracerebral hemorrhage on initial CT scan No immediate need for surgical evacuation of the hematoma exclusion criteria: Under 18 years old Bleeding caused by an aneurysm Malignancy or structural lesions of the brain Pregnancy or breastfeeding Known coagulation disorders Renal failure History of thrombosis Any type of bleeding other than ICH

In the intervention group, patients will receive standard treatment (blood pressure control, head elevation, normal saline, blood glucose control, subcutaneous heparin, anticonvulsants, acetaminophen, mannitol) plus tranexamic acid (Raha Pharmaceutical) at 15–20 mg/kg IV bolus over 10 minutes, then 15 mg/kg IV infusion over 8 hours. The control group will receive only standard treatments without tranexamic acid.

Intracerebral hemorrhage volume (ICH volume)

In this study, randomization will be performed using block randomization at the individual level. After determining the sample size (50 patients) and two study groups (intervention and control), a random allocation sequence consisting of 25 blocks of size two (block size = 2) will be generated using a computer-based random number generator prior to study initiation. Patients will be enrolled consecutively based on the time of entry into the study, and after confirming eligibility criteria and obtaining informed consent, they will be assigned sequentially according to the pre-generated randomization list. The randomization list will be kept confidential, and the investigator responsible for patient recruitment will be unaware of group allocation prior to assignment.