Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID04566991

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)

Led by Aditya S. Pandey, MD · Updated on 2025-11-28

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Aneurysmal subarachnoid hemorrhage (aSAH) is a serious condition with high risk of death and complications shortly after onset. This trial investigates the safety and effectiveness of deferoxamine mesylate (DFO), a drug that binds free iron to prevent brain injury caused by iron-related damage. Researchers aim to understand if DFO can improve outcomes for patients admitted with aSAH at the University of Michigan. Participants will be randomly assigned to receive one of two doses of intravenous deferoxamine (32 mg/kg or 48 mg/kg) or a placebo (normal saline). The treatment involves three doses administered over three days, each given 24 hours apart at a fixed rate. The trial includes a double-blind design where neither participants nor researchers know the assigned treatment to ensure unbiased results. During the study, patients will be monitored closely with assessments including the Utility-weighted modified Rankin Scale at six months after hospital discharge to measure recovery. Additional evaluations such as cognitive tests, oxygen levels, and brain complication checks will occur during and after treatment. Information will be collected for up to six months post-discharge to understand the long-term effects and safety of the treatments.

CONDITIONS

Brief Title

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aneurysmal subarachnoid hemorrhage confirmed by vascular imaging
  • Aneurysm treated with endovascular or microsurgical intervention
  • Hunt-Hess score of 4 or less
  • Modified Fisher Grade I to IV
  • Glasgow Coma Scale 7 or higher after External Ventricular Drain placement if needed
  • First dose of study drug can be given within 24 hours of symptom onset
  • Functional independence before hemorrhage, Modified Rankin Scale 1 or less
  • Informed consent given by patient or legal authorized representative
Not Eligible

You will not qualify if you...

  • Previous hypersensitivity to or treatment with deferoxamine
  • Presence of giant aneurysm larger than 25 mm
  • Severe iron deficiency anemia with hemoglobin 7 g/dL or less or transfusion dependent
  • Irreversibly impaired brainstem function
  • Abnormal kidney function with serum creatinine over 2 mg/dL
  • Pre-existing severe disability, Modified Rankin Scale 2 or more
  • Coagulopathy or use of anti-platelet or anticoagulant drugs
  • Severe hearing loss
  • Chronic pulmonary disease limiting daily activities or requiring home oxygen
  • Acute pulmonary disease needing high oxygen support in prior 72 hours
  • Taking iron supplements with more than 325 mg of ferrous iron
  • Pregnancy or nursing
  • Life expectancy less than 90 days from other health problems
  • Participation in another experimental therapy trial (observational studies allowed)
  • Prior liver dysfunction
  • Known low blood cell counts (platelets less than 50,000, neutrophils less than 500)
  • Current use of prochlorperazine
  • History of severe psychiatric disorder

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 days

Participants receive three intravenous doses of Deferoxamine or placebo over three consecutive days.

3 visits (in-person) on days 1, 2, and 3

Follow-up

Duration - Up to 6 months after hospital discharge

Participants are monitored for safety and outcomes including cognitive assessment and cerebrospinal fluid diversion up to 6 months after hospital discharge.

Visits at hospital discharge (approximately 3-4 weeks) and at 6 months

Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

S

Sravanthi Koduri

A

Aditya Pandey, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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