Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH) (DISH)

  • STATUS
    Recruiting
  • End date
    Oct 25, 2025
  • participants needed
    120
  • sponsor
    Aditya S. Pandey, MD
Updated on 25 April 2022

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.

Details
Condition Aneurysmal Subarachnoid Hemorrhage
Treatment Placebo, Deferoxamine
Clinical Study IdentifierNCT04566991
SponsorAditya S. Pandey, MD
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

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)
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