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RecruitingNCT04566991

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Aditya S. Pandey, MD · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDeferoxamineThere 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.
DRUGPlaceboThere 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.

Timeline

Start date
2022-03-20
Primary completion
2027-10-01
Completion
2027-10-01
First posted
2020-09-28
Last updated
2025-11-28

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04566991. Inclusion in this directory is not an endorsement.