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NCT Number: NCT04566991

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

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.

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Koduri Sravanthi

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deferoxamine

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.

Other names: Desferal

Placebo

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.

Other names: Normal Saline

Primary outcomes

  1. Utility-weighted modified Rankin Scale (UW-mRS) at 6 months

    Time frame: 6 months (after hospital discharge)

    Overall a Bayesian, longitudinal model will be used, this will be adjusted for baseline expected 6 month mRS using the FRESH score. At baseline, the expected 6 month UW-mRS (based on prognostic variables such as age and Hunt Hess) will be entered as the first value for the patient. Therefore, patients with greater severity at baseline, who achieve excellent outcomes will contribute a larger treatment effect. Similarly, patients with greater severity who have disability, but perform better than expected can still contribute useful information.

Secondary outcomes

  1. Montreal Cognitive Assessment (MOCA)

    Time frame: At discharge from hospital (approximately 3-4 weeks)

    Montreal cognitive assessment is a rapid sensitive screening tool for assessment of impaired cognitive function. The main domains of MoCA scale include attention, executive functions, memory, language, attention, naming, orientation, and visual-spatial ability. The total score is 30 points. A score of 25 points or less indicated impaired cognitive function. For patients with less than 12 years of education, one point was added to the total score.

  2. Montreal Cognitive Assessment (MOCA)

    Time frame: 6 months (after hospital discharge)

    Montreal cognitive assessment is a rapid sensitive screening tool for assessment of impaired cognitive function. The main domains of MoCA scale include attention, executive functions, memory, language, attention, naming, orientation, and visual-spatial ability. The total score is 30 points. A score of 25 points or less indicated impaired cognitive function. For patients with less than 12 years of education, one point was added to the total score.

  3. Percentage of patients requiring permanent cerebrospinal fluid (CSF) diversion due to hydrocephalus at 6 months

    Time frame: 6 months

  4. Partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2) ratio (worst value for each parameter for each day of infusion, and 48 hours after end of infusion)

    Time frame: up to 48 hours after day 3 infusion

    Worst value for each parameter for each day of infusion, and 48 hours after end of infusion.

  5. To estimate the proportion of non-intubated participants at each dose who experience intubation or initiation of non-invasive positive pressure ventilation during the DFO

    Time frame: infusion days 1-3

  6. Incidence of delayed cerebral ischemia/vasospasm

    Time frame: up to 14 days after aSAH

    This is based on radiographic evidence on computed tomography angiogram and clinical correlation with neurologic exam.

Study contacts

Contact information is provided by the study sponsor or research team.

Aditya Pandey, MD

CONTACT

[email protected]

734-615-2763

Sravanthi Koduri

CONTACT

[email protected]

734-647-7960

Sponsors and collaborators

Lead sponsor

Aditya S. Pandey, MD

Other

Registry information

Official study title

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)

Acronym: DISH

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 28, 2020
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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