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Chelating Agent

Deferoxamine for Subarachnoid Hemorrhage (DISH Trial)

Phase 2

Recruiting

Led By Aditya Pandey, MD

Research Sponsored by Aditya S. Pandey, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Functional independence prior to SAH, Modified Rankin Scale (mRS) score of 1 or less

Modified Fisher Grade I-IV

Must not have

Pre-existing severe disability, mRS score of 2 or higher

Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or on home oxygen (O2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months (after hospital discharge)

Summary

This trial will evaluate the safety and efficacy of clinical deferoxamine for the treatment of aSAH.

Who is the study for?

This trial is for patients with a recent brain aneurysm bleed who were independent before the event, can start treatment within 24 hours, and have had their aneurysm secured. They must be able to give consent and not have severe kidney issues, hearing loss, low blood counts, or allergies to deferoxamine.

What is being tested?

The study tests if Deferoxamine (DFO), which binds iron in the body to prevent damage from free radicals, is safe and effective for treating bleeding from a brain aneurysm. Participants will receive either DFO at two different doses or a placebo.

What are the potential side effects?

Deferoxamine may cause side effects such as allergic reactions, changes in vision or hearing, breathing difficulties, lowered blood pressure upon standing up quickly and infections due to its impact on iron levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was independent in daily activities before my stroke.

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My brain hemorrhage is classified between Grade I and IV.

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My aneurysm was treated with a procedure inside the vessel or surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant disability, with difficulty in daily activities.

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I have a serious lung condition or need home oxygen.

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I have severe anemia or need blood transfusions often.

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I have severe hearing loss.

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I have a blood clotting disorder or I'm taking medication to prevent blood clots.

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I am taking iron supplements with more than 325 mg of ferrous iron.

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I have had liver problems in the past.

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My kidney function is not normal, with a creatinine level over 2 mg/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months (after hospital discharge)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months (after hospital discharge)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months (after hospital discharge) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Incidence of delayed cerebral ischemia/vasospasm

Montreal Cognitive Assessment (MOCA)

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)