Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Aditya S. Pandey, MD
Study ID
NCT04566991
Phase
PHASE2
Status
Recruiting
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Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Deferoxamine — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 20, 2022
Status verified
Nov 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Deferoxamine lower dose
    Deferoxamine 32 Milligram Per Kilogram (mg/kg)
  • Experimental: Deferoxamine higher dose
    Deferoxamine 48 mg/kg
  • Placebo Comparator: Placebo
    normal saline

Primary Outcome Measure

Utility-weighted modified Rankin Scale (UW-mRS) at 6 months [ Time Frame: 6 months (after hospital discharge) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Koduri Sravanthi
[email protected]

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By research site
University of Michigan· Ann Arbor, MI

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