NCT04566991 · Aditya S. Pandey, MD
Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)
(DISH)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 28, 2025 · Source of record for eligibility and locations