RecruitingPhase 2NCT04566991

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)

Sponsor

Aditya S. Pandey, MD

Enrollment

120 participants

Start Date

Mar 20, 2022

Study Type

INTERVENTIONAL

Conditions

Aneurysmal Subarachnoid Hemorrhage

Summary

Aneurysmal subarachnoid hemorrhage (aSAH) has a high incidence of mortality and significant morbidity, with mortality exceeding 30% in the first two days.The initial injury is related to increasing intracranial pressure, cerebral edema, and neuronal injuries associated with the release of iron. Iron has been shown to increase the incidence of cerebral edema, ischemia, and formation of hydrocephalus. Deferoxamine mesylate (DFO), a hydrophilic chelator, creates a stable complex with free iron thus preventing the formation of iron related free radicals. This trial will evaluate the safety and efficacy of clinical deferoxamine for the treatment of aSAH for patients that are admitted to the hospital at the University of Michigan. Eligible participants will be enrolled and randomized to 1 of 2 doses of Deferoxamine or placebo (saline). Information regarding the patients will be collected and followed for up to 6 months post discharge.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called deferoxamine — which is normally used to remove excess iron from the body — can help people recover better after a brain bleed caused by a burst aneurysm (called aneurysmal subarachnoid hemorrhage, or aSAH). After a brain bleed, blood breaks down in the brain and releases iron, which may cause additional damage. Deferoxamine may help by binding that iron and reducing harm to brain tissue. Participants will receive either deferoxamine or a placebo (inactive treatment) after their aneurysm has been treated. The study measures recovery outcomes to see if the drug leads to better brain function. You may be eligible if: - You had a confirmed brain bleed from a burst aneurysm - The aneurysm has already been treated with surgery or a minimally invasive procedure - You were functionally independent before this event - You are between 18 and 80 years old - Treatment can begin within 24 hours of your symptoms starting You may NOT be eligible if: - You have a known allergy to deferoxamine or have used it before - You have severe anemia or kidney problems - You are pregnant or nursing - You have serious lung disease, blood clotting problems, or severe psychiatric history - You were already significantly disabled before this event Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDeferoxamine

There will be 3 doses given to the patients days 1-3. Dose will be given intravenous with a fixed rate of 7.5 milligram per kilogram per hour (mg/kg/hr). The second dose will be given 24 hours after the first dose, and the third dose will be given 48 hours after the initial dose. Patients will be randomized to 32 mg/kg or 48 mg/kg of Deferoxamine.

DRUGPlacebo

There will be 3 doses given to the patients days 1-3. Dose will be given intravenous with a fixed rate of 7.5 mg/kg/hr. The second dose will be given 24 hours after the first dose, and the third dose will be given 48 hours after the initial dose.