Using Deferoxamine to treat Aneurysmal Subarachnoid Hemorrhage
Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)
This study is testing if a drug called deferoxamine can help people with aneurysmal subarachnoid hemorrhage recover better by reducing complications from iron release.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT04566991 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of deferoxamine mesylate in patients with aneurysmal subarachnoid hemorrhage (aSAH). Participants will be randomly assigned to receive either deferoxamine or a placebo within 24 hours of symptom onset. The study aims to assess the impact of deferoxamine on reducing complications associated with iron release, such as cerebral edema and ischemia. Patient outcomes will be monitored for up to six months post-discharge to determine the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include patients with confirmed aSAH who have undergone aneurysm treatment and have a Glasgow Coma Scale score of 7 or higher.
Not a fit: Patients with severe iron deficiency anemia, significant pre-existing disabilities, or those with certain coagulopathies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and morbidity associated with aSAH.
How similar studies have performed: While the use of deferoxamine in this context is novel, similar approaches in managing iron-related complications have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Aditya Pandey, MD — University of Michigan
- Study coordinator: Sravanthi Koduri
- Email: skoduri@med.umich.edu
- Phone: 734-647-7960
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.