Evaluation of Deferoxamine Mesilate in Patients with Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial

The primary objective of the Deferoxamine in Aneurysmal Subarachnoid Hemorrhage trial (DASH) is to evaluate the effects of **deferoxamine** on patients with aneurysmal subarachnoid hemorrhage. The primary outcome measure is the presence of new ischemia as detected by control imaging at two weeks and six months. This is clinically relevant as new ischemia can significantly impact patient recovery and long-term neurological outcomes. The study aims to determine whether deferoxamine can reduce the incidence of ischemic events, thereby potentially improving patient prognosis and quality of life.

The clinical trial focuses on patients diagnosed with **subarachnoid hemorrhage**. The study population includes both male and female participants, aged between 18 and 85 years. Participants are required to be in good general health, specifically in a good clinical grade, as indicated by a World Federation of Neurological Surgeons (WFNS) score of 1-3 and a Glasgow Coma Scale (GCS) score of 13-15 at the time of randomization. The trial does not involve a vulnerable population. Participants must have a confirmed diagnosis of subarachnoid hemorrhage via CT on admission, with no history of traumatic origin, and must be eligible for inclusion within 72 hours of the hemorrhage. Additionally, a saccular intracranial aneurysm must be proven by cerebral angiography or CTA, and surgical or endovascular obliteration must be successfully performed. The ability to obtain written informed consent from the patient is also a requirement. The sponsor has not provided information regarding the total number of participants in the trial.

The clinical trial is designed to evaluate the effects of **deferoxamine mesilate** in patients with aneurysmal **subarachnoid hemorrhage**. This study is structured as a randomized, double-blind, controlled trial, integrating both Phase I and Phase II methodologies. The trial is expected to span approximately three years, with an estimated recruitment start date of December 1, 2022, and an anticipated end date of December 1, 2025. Participants will be randomly assigned to receive either the active treatment, Deferoxamine Noridem 500mg, administered intravenously, or a placebo, NaCl 0.9%. The primary outcome measure is the presence of new ischemia at control imaging conducted at two weeks and six months post-treatment. Secondary outcomes include serum ferritin levels and assessments using various neurological and functional outcome scales such as mRS, GOS-E, and EQ-5D at six months.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is confirmed based on criteria such as age (18-85 years), diagnosis of subarachnoid hemorrhage by CT, and successful surgical or endovascular obliteration of a saccular intracranial aneurysm. Participants must be in good clinical grade (WFNS 1-3, GCS 13-15) at the time of randomization and able to provide written informed consent. Follow-up visits are scheduled at two weeks and six months to monitor the primary and secondary endpoints. The end-of-study visit will occur at the six-month mark, concluding the participant's involvement in the trial.

Participant involvement is expected to last for six months, with conditions for early termination including withdrawal of consent, adverse events, or any medical condition that contraindicates continued participation. The trial aims to provide valuable insights into the therapeutic potential of deferoxamine mesilate in improving outcomes for patients with subarachnoid hemorrhage.

The clinical trial involves the administration of **Deferoxamine Noridem 500mg**, a pharmaceutical product formulated as a **solution for injection/infusion**. The active substance in this experimental medication is **deferoxamine mesilate**, a chemical compound. The medication is administered via the **intravenous** route. The frequency and specific dosing schedule are not detailed in the provided data. The product is manufactured by Noridem Enterprises Ltd and is identified by the marketing authorization number 21179. The trial aims to evaluate the effects of deferoxamine in patients with aneurysmal subarachnoid hemorrhage, with primary and secondary outcome measures focusing on ischemia and various neurological and functional outcomes.

In addition to the experimental treatment, the study utilizes **NaCl 0.9%** as a comparator treatment. This substance serves as a placebo in the trial. The pharmaceutical form, active substance, and administration route for NaCl 0.9% are not specified in the provided data. The use of NaCl 0.9% is intended to provide a control for assessing the efficacy and safety of the experimental medication, Deferoxamine Noridem 500mg. Participant compliance with the treatment regimen is monitored throughout the study, although specific compliance measures are not detailed in the available information.

Efficacy in the clinical trial titled "Deferoxamine in Aneurysmal Subarachnoid Hemorrhage trial (DASH)" will be assessed using both primary and secondary outcome measures. The primary endpoint is the presence of new **ischemia** detected through control imaging at two specific timepoints: 2 weeks and 6 months post-treatment. This will involve imaging techniques to identify any new ischemic events in patients who have experienced an aneurysmal subarachnoid hemorrhage.

Secondary endpoints include the measurement of serum ferritin levels and the evaluation of neurological and functional outcomes using validated scales such as the modified Rankin Scale (mRS), the Glasgow Outcome Scale-Extended (GOS-E), and the EQ-5D at 6 months. These assessments will provide a comprehensive evaluation of the patient's recovery and functional status following the intervention. The data collection will be scheduled at the 6-month mark to ensure a thorough analysis of the long-term effects of the treatment.