Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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 or Peking University Health Science Center. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aditya S. Pandey, MD
• Collaborator: Michigan Medicine PKUHSC Joint Institute for Translational & Clinical Research
• Treatments: Deferoxamine

Criteria

Inclusion Criteria:

• Aneurysmal SAH confirmed with vascular imaging

• Aneurysm treated with endovascular or microsurgical intervention

• Hunt-Hess ≤ 4

• Modified Fisher Grade I-IV

• Glasgow Coma Scale (GCS) ≥ 7 following External Ventricular Drain (EVD) placement if indicated

• First dose of drug can be administered within 24 hours of symptom onset

• Functional independence prior to SAH, Modified Rankin Scale (mRS) ≤ 1

• Informed consent obtained by patient or legal authorized representative (LAR)

Exclusion Criteria:

• Previous hypersensitivity to or treatment with deferoxamine

• Presence of giant aneurysm (>25 mm in size)

• Known severe iron deficiency anemia, Hemoglobin (Hgb) g/dl ≤ 7 or transfusion dependent

• Irreversibly impaired brainstem function

• Abnormal renal function, Serum Creatinine> 2 mg/dL

• Pre-existing severe disability, mRS ≥ 2

• Coagulopathy, including use of anti-platelet or anticoagulant drugs

• Known severe hearing loss

• Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or on home oxygen (O2)

• Taking iron supplements containing > 325 mg of ferrous iron

• Pregnancy

• Life expectancy less than 90 days due to co-morbidities

• Concurrent participation in another research protocol for investigation of another experimental therapy, though observational studies are allowed

• Prior history of hepatic dysfunction

• Known cytopenia (platelets < 50,000, Absolute neutrophil count < 500)