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IRCT20241016063386N2 IRCT 2025-12-27 Oroumia University of Medical Sciences Evaluating the effect of Tranexamic Acid on the Prognosis of Patients with Intracerebral Hemorrhage Evaluating the effect of Tranexamic Acid on the Prognosis of Patients with Intracerebral Hemorrhage 2026-02-20 anticipated 50 Recruiting https://irct.ir/trial/88246 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: To provide documented clinical evidence to guide decision-making regarding the inclusion of tranexamic acid (TXA) in treatment protocols for patients with spontaneous intracerebral hemorrhage (sICH), in a manner that is compatible with the capacities and limitations of the country's health system and leads to a reduction in mortality and disability due to this disease, Randomization description: 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. 3 Nontraumatic intracerebral hemorrhage. Intervention 1: In the intervention group, in addition to standard treatment, Tranexamic Acid (manufactured by Raha Pharmaceutical Company) will be administered at a dose modified based on the patient's weight:Initial dose: 15–20 mg/kg as an intravenous bolus over 10 minutes.Maintenance dose: 15 mg/kg as an intravenous infusion over 8 hours.Standard treatment in this group includes the following measures:Blood pressure control in the range of 130–150 mmHgKeeping the patient's head elevated at a 30-degree angleAdministration of normal saline to maintain hydration and blood volumeBlood glucose control in the range of 150–180 mg/dLSubcutaneous heparin administration after hemodynamic stabilization to prevent thrombosisCommencement of anticonvulsants in case of seizuresFever control with acetaminophenMannitol usage in case of increased intracranial pressure (ICP). Intervention 2: In the control group, patients will receive standard treatment, which includes the following measures:Blood pressure control in the range of 130–150 mmHgKeeping the patient's head elevated at a 30-degree angleAdministration of normal saline to maintain hydration and blood volumeBlood glucose control in the range of 150–180 mg/dLSubcutaneous heparin administration after hemodynamic stabilization to prevent thrombosisCommencement of anticonvulsants in case of seizuresFever control with acetaminophenUse of mannitol in case of increased intracranial pressure (ICP). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I will make a decision to publish after the completion of the project and according to the results
public Dr.Fatemeh Hamzeh
Imam Khomeini University Hospital., Ershad AVE.,Modarres Blvd., Urmia., IRAN
Urmia Iran (Islamic Republic of) 5718748983 0044 3237 5907 hamzeh.f@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr.Fatemeh Hamzeh
Imam Khomeini University Hospital., Ershad AVE.,Modarres Blvd., Urmia., IRAN
Urmia Iran (Islamic Republic of) 5718748983 +98 44 3237 5907 hamzeh.f@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Age ≥ 18 years Diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by initial brain CT scan Admission to the emergency department Hemodynamic stability after initial supportive management Provision of written informed consent by the patient or legal guardian 18 years no limit Both Urgent need for surgical intervention for hematoma evacuation Intracerebral hemorrhage secondary to trauma, aneurysm, malignancy, or structural brain lesions Pregnancy or breastfeeding Known coagulation disorders or use of uncontrollable anticoagulant therapy Moderate to severe renal failure History of thrombosis or active thromboembolic disease Hemodynamic instability despite initial therapeutic interventions Inability to obtain informed consent from the patient or legal guardian due to clinical or legal reasons I61 Nontraumatic intracerebral hemorrhage Treatment - Drugs Treatment - Drugs In the intervention group, in addition to standard treatment, Tranexamic Acid (manufactured by Raha Pharmaceutical Company) will be administered at a dose modified based on the patient's weight:Initial dose: 15–20 mg/kg as an intravenous bolus over 10 minutes.Maintenance dose: 15 mg/kg as an intravenous infusion over 8 hours.Standard treatment in this group includes the following measures:Blood pressure control in the range of 130–150 mmHgKeeping the patient's head elevated at a 30-degree angleAdministration of normal saline to maintain hydration and blood volumeBlood glucose control in the range of 150–180 mg/dLSubcutaneous heparin administration after hemodynamic stabilization to prevent thrombosisCommencement of anticonvulsants in case of seizuresFever control with acetaminophenMannitol usage in case of increased intracranial pressure (ICP) In the control group, patients will receive standard treatment, which includes the following measures:Blood pressure control in the range of 130–150 mmHgKeeping the patient's head elevated at a 30-degree angleAdministration of normal saline to maintain hydration and blood volumeBlood glucose control in the range of 150–180 mg/dLSubcutaneous heparin administration after hemodynamic stabilization to prevent thrombosisCommencement of anticonvulsants in case of seizuresFever control with acetaminophenUse of mannitol in case of increased intracranial pressure (ICP) (Intracerebral Hemorrhage Volume). Timepoint: CT scan and calculation of bleeding volume will be performed at baseline, 48 hours after admission, and on the seventh day after study entry. Method of measurement: The volume of intracerebral hemorrhage is calculated using a brain CT scan and based on the standard ABC/2 formula. Oroumia University of Medical Sciences Approved 2025-12-03 Imam Khomeini Educational and Medical Center - Urmia University of Medical Sciences (Research Ethics Imam Khomeini University Hospital., Ershad AVE.,Modarres Blvd., Urmia., IRAN Urmia West Azarbaijan Iran (Islamic Republic of)