Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAditya S. Pandey, MD

About this trial

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 criteria

Qualifiers

Aneurysmal SAH confirmed with vascular imaging

Aneurysm treated with endovascular or microsurgical intervention

Hunt-Hess ≤ 4

Modified Fisher Grade I-IV

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Deferoxamine
  • Placebo

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Aditya S. Pandey, MD

Lead sponsor

University of Michigan

Sponsor institution