efficacy of intravenous vitamin C combined with intravenous tranexamic acid in improving outcomes of intracerebral/intraventricular hemorrhages in non-traumatic ICH patients

-Evaluation of the combined therapeutic effect of intravenous tranexamic acid and intravenous Vitamin C in preventing the progression of intracerebral hemorrhage, improving three‑month functional impairment (based on changes in the mRS score) and reducing mortality in patients with non‑traumatic ICH patients.

The clinical trial is a parallel-group, double-blind, randomized, phase 3 study with a control group, involving 60 patients. Permuted Block Randomization will be used to allocate patients into the two control and intervention groups.

Study Design: Double-blind trial at Imam Reza Hospital, Tabriz, monitoring patients for 90 days post-intervention. Blinding: Both participants and the executive study team will be blinded to group assignments (intervention vs. control). Follow-up: Assessments conducted at 24 hours, 3, 7, 30, and 90 days post-admission.

Inclusion Criteria: Adults (>18 yrs) with acute, non-traumatic intracerebral hemorrhage, presenting within 6 hours of symptom onset. Exclusion Criteria: Patients with hemorrhage due to anticoagulants, thrombolysis, or underlying structural issues (e.g., AVM, aneurysm, tumor).

Intervention Group: Receives a loading dose of IV tranexamic acid (1g in 100ml NS), followed by 1g IV infusion over 8 hours (total 2g/24h), plus 4g IV vitamin C daily for 4 days. Control Group: Receives only IV tranexamic acid as part of standard ICH care. Treatment Duration: Tranexamic acid for 24 hours, vitamin C for 4 days in the intervention group.

Prevention of intracerebral hemorrhage progression, improvement in three-month functional outcomes (based on changes in the modified Rankin Scale - mRS), and reduction in mortality rate in patients with non-traumatic intracerebral hemorrhage

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.

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.

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.

Available upon publication of the primary results and for three years thereafter.

Qualified researchers from academic or non-profit institutions with a sound research proposal.

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.

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.

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.