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IRCT20170609034406N15 IRCT 2026-03-31 Tabriz University of Medical Sciences Evaluation of the combined therapeutic effects of intravenous Vitamin C and intravenous tranexamic acid on improving outcomes in patients with non‑traumatic ICH efficacy of intravenous vitamin C combined with intravenous tranexamic acid in improving outcomes of intracerebral/intraventricular hemorrhages in non-traumatic ICH patients 2026-06-22 anticipated 60 Pending https://irct.ir/trial/89356 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Double‑blind, Randomized, Block‑randomized Clinical Trial. Intervention Group: Intravenous TXA + Intravenous Vitamin C. Control Group: Intravenous TXA, along with other standard treatments and care for ICH. Monitoring: At 24 hours, 3 days, 7 days, 30 days, and 90 days, Randomization description: In this study, Permuted Block Randomization is used to allocate patients into two groups: the control and the intervention groups. A total of 25 blocks of 4 participants are planned. In this method, each block contains an equal number of patients in the intervention and control groups. Random numbers in this study are generated using Microsoft Excel to create the random block assignments as well as the random allocation of patients to the groups, Blinding description: In this phase 3 clinical trial, a double‑blind design will be implemented to ensure the validity of the results and to minimize any potential sources of bias. This approach guarantees that neither the participants (patients) nor the study personnel (including physicians, nurses, data collectors, and outcome assessors) are aware of the treatment allocation for each patient within the intervention or control groups. According to the study protocol, the control group will receive intravenous tranexamic acid, while the intervention group will receive intravenous tranexamic acid in combination with intravenous vitamin C. To maintain blinding, both injectable agents (tranexamic acid and vitamin C) will be prepared and packaged in a manner that ensures complete similarity in appearance, color, volume, odor, and other physical characteristics. All injectable solutions will be labeled with unique identification codes, and the code‑allocation key (indicating which code corresponds to which treatment combination) will be securely kept by an independent individual or entity with no involvement in patient care, trial execution, or data collection and analysis. This strategy ensures that information regarding the administration of active vitamin C remains concealed until the completion of data collection and analysis, thereby preventing any potential influence on clinical judgment or outcome assessment. 3 Non-traumatic intracerebral and intraventricular hemorrhage. Intervention 1: Intervention group: Patients in the intervention group will receive 1 gram of intravenous tranexamic acid diluted in 100 milliliters of normal saline as a loading dose, followed by an intravenous infusion of 1 gram over eight hours (a total of 2 grams of intravenous tranexamic acid within 24 hours), along with 4 grams of intravenous vitamin C daily for four days. Intervention 2: Control group: They will receive only intravenous tranexamic acid in addition to other standard treatments and care for ICH. Yes - There is a plan to make this available What will be shared: Deidentified IPD (baseline and follow-up clinical variables, outcomes, adverse events), study protocol, statistical analysis plan, blank informed consent form, analytic code, and data dictionary. When: Available upon publication of the primary results and for three years thereafter. To whom: Qualified researchers from academic or non-profit institutions with a sound research proposal. Conditions: Non-commercial use for scientifically and ethically appropriate projects; approval by an institutional review board or ethics committee when applicable; execution of a data use agreement that protects participant privacy. Where to obtain: Contact the Principal Investigator via email (forouzan.abbasgholizadeh1998@gmail.com). Documents may also be posted on the Tabriz University of Medical Sciences repository if available. How to obtain: Submit a brief proposal and analysis plan to the Principal Investigator. Requests are reviewed by the study steering team within 30 days. If approved, a data use agreement will be executed and the deidentified dataset, code, and data dictionary will be shared via a secure link. Comments:
public Afshin Gharekhani
Golghasht Ave., Faculty of Pharmacy/Tabriz University of Medical Sciences/Daneshgah Street/Tabriz/Iran. P.O.Box 5166
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3334 1315 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Afshin Qarekhani
Golghasht Ave., Faculty of Pharmacy/Tabriz University of Medical Sciences/Daneshgah Street/Tabriz/Iran. P.O.Box 5166
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3334 1315 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Individuals over 18 years of age with acute, non-traumatic intracerebral hemorrhage, within a maximum of 6 hours from the onset of bleeding 18 years no limit Both Patients with intracerebral hemorrhage secondary to anticoagulant use, thrombolysis, or known structural abnormalities such as arteriovenous malformations (AVMs), aneurysms, or tumors Patients with contraindications to tranexamic acid (such as active intravascular clotting, a history of thromboembolic diseases, or hypersensitivity to tranexamic acid) Modified Rankin Scale (mRS) >4 Glasgow coma scale <5 Intracerebral hemorrhage secondary to trauma Subarachnoid hemorrhage (SAH) Subdural hemorrhage (SDH) Epidural hemorrhage (EDH) Pregnant or lactating women at the time of randomization Geographical or other factors that hinder follow-up at 90 days, such as lack of a permanent address or contact phone number I61 Nontraumatic intracerebral hemorrhage Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group will receive 1 gram of intravenous tranexamic acid diluted in 100 milliliters of normal saline as a loading dose, followed by an intravenous infusion of 1 gram over eight hours (a total of 2 grams of intravenous tranexamic acid within 24 hours), along with 4 grams of intravenous vitamin C daily for four days. Control group: They will receive only intravenous tranexamic acid in addition to other standard treatments and care for ICH. Functional outcome measured by the Modified Rankin Scale (mRS) score at day ninety after randomization. Timepoint: Baseline before randomization and day ninety (or discharge day) after randomization. Method of measurement: Use of the modified Rankin Scale questionnaire (range 0 to 6) administered in person by a trained assessor who is blinded to group allocation. Hematoma expansion defined as an increase in intracerebral hemorrhage volume of at least thirty three percent or at least six milliliters between baseline and follow up imaging. Timepoint: Baseline imaging at enrollment and follow up imaging at twenty four to seventy two hours after randomization. Method of measurement: Non contrast computed tomography scans with hematoma volume measured by the ABC divided by two method or by planimetry on the hospital imaging workstation read by a radiologist who is blinded to group allocation. All‑cause mortality up to the day of discharge (or death) following randomization. Timepoint: From the time of randomization until the day of discharge (or death). Method of measurement: Review of the hospital record and follow-up telephone assessment by the blinded assessor, confirmed by official records where permitted. Tabriz University of Medical Sciences Approved 2026-03-17 Ethics Committee of Tabriz University of Medical Sciences No 2 Central Building , Tabriz University of Medical Sciences , Golgasht Street , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)