Recruiting
Phase 2

Deferoxamine

Sponsor:

Aditya S. Pandey, MD

Code:

NCT04566991

Conditions

Aneurysmal Subarachnoid Hemorrhage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deferoxamine

Placebo

Study Details

Brief 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

Aneurysmal Subarachnoid Hemorrhage

Study ID

NCT04566991

Start date

Mar 20, 2022

Status verified date

Nov, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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
  • Chronic pulmonary disease that limits basic activities of daily living at baseline, or requires the use of home oxygen.
  • Acute pulmonary disease with the need for any of the following - in a 72 hour period prior to enrollment: >4L/minute nasal cannula (or equivalent O2 delivery via face mask/ tent), heated-high flow nasal cannula, noninvasive positive pressure ventilation, and in intubated patients FiO2>45% or positive end-expiratory pressure (PEEP) > 8cmH2O. This does not include the use of supplemental oxygen in any form for pre-oxygenation, apneic oxygenation, or peri-procedural support alone.
  • Taking iron supplements containing > 325 mg of ferrous iron
  • Pregnancy or nursing
  • 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)
  • Current use of prochlorperazine
  • History of severe psychiatric disorder

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Deferoxamine

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sravanthi Koduri

734-647-7960skoduri@med.umich.edu

Aditya Pandey, MD

734-615-2763adityap@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Koduri Sravanthi

skoduri@med.umich.edu

More Information

Sponsor

Aditya S. Pandey, MD

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

  • Deferoxamine
  • Placebo

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aditya S. Pandey, MD on 2025-11-28.