Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

NCT ID: NCT04566991

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2027-10-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Deferoxamine lower dose

Deferoxamine 32 Milligram Per Kilogram (mg/kg)

Group Type: EXPERIMENTAL

Deferoxamine

Intervention Type: 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.

Deferoxamine higher dose

Deferoxamine 48 mg/kg

Group Type: EXPERIMENTAL

Deferoxamine

Intervention Type: 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

normal saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Desferal; Normal Saline

Eligibility 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aditya S. Pandey, MD

OTHER

Sponsor Role: lead

Responsible Party

Aditya S. Pandey, MD

Associate Professor of Neurosurgery and Associate Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aditya Pandey, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sravanthi Koduri

Role: CONTACT

skoduri@med.umich.edu

734-647-7960

Aditya Pandey, MD

Role: CONTACT

adityap@umich.edu

734-615-2763

Facility Contacts

Koduri Sravanthi

Role: primary

skoduri@med.umich.edu

Other Identifiers

HUM00163868

Identifier Type: -

Identifier Source: org_study_id