Aneurysmal Subarachnoid HemorrhagePhase 2DISHNCT04566991
Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)
A Phase 2 study testing Deferoxamine in people with Aneurysmal Subarachnoid Hemorrhage, run by Aditya S. Pandey, MD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Deferoxamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2022to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Koduri Sravanthi, skoduri@med.umich.edu
About this study
Official title: Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)
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.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Deferoxamine, Placebo
- Keywords
- Deferoxamine, Placebo
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeferoxamineDrug
Also called Desferal
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.
PlaceboDrug
Also called Normal Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| Deferoxamine lower dose | Experimental | Deferoxamine 32 Milligram Per Kilogram (mg/kg) Receives: Drug: Deferoxamine |
| Deferoxamine higher dose | Experimental | Deferoxamine 48 mg/kg Receives: Drug: Deferoxamine |
| Placebo | Placebo comparator | normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility-weighted modified Rankin Scale (UW-mRS) at 6 months
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.
Measured: 6 months (after hospital discharge)
Secondary outcomes (6)
Montreal Cognitive Assessment (MOCA)
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.
Measured: At discharge from hospital (approximately 3-4 weeks)
Montreal Cognitive Assessment (MOCA)
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.
Measured: 6 months (after hospital discharge)
Percentage of patients requiring permanent cerebrospinal fluid (CSF) diversion due to hydrocephalus at 6 months
Measured: 6 months
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)
Worst value for each parameter for each day of infusion, and 48 hours after end of infusion.
Measured: up to 48 hours after day 3 infusion
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
Measured: infusion days 1-3
Incidence of delayed cerebral ischemia/vasospasm
This is based on radiographic evidence on computed tomography angiogram and clinical correlation with neurologic exam.
Measured: up to 14 days after aSAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start20 Mar 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aditya S. Pandey, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aditya S. Pandey, MD, University of Michigan
- Investigators
- Aditya Pandey, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566991
- Sponsor's protocol ID
- HUM00163868
- Acronym
- DISH
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2020
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (DISH)
- ClinicalTrials.gov ID
- NCT04566991
- Acronym / sponsor ID
- DISH / HUM00163868
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- Deferoxamine, Placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aditya S. Pandey, MDUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deferoxamine lower dose | Experimental | Drug: DeferoxamineDeferoxamine 32 Milligram Per Kilogram (mg/kg) |
| Deferoxamine higher dose | Experimental | Drug: DeferoxamineDeferoxamine 48 mg/kg |
| Placebo | Placebo comparator | Drug: Placebonormal saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeferoxamineAlso: DesferalThere 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. | Drug | Deferoxamine higher dose, Deferoxamine lower dose |
| PlaceboAlso: Normal SalineThere 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. | Drug | Placebo |
Primary outcome
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.
6 secondary outcomes
Montreal Cognitive Assessment (MOCA)
Time frame: At discharge from hospital (approximately 3-4 weeks)
Montreal Cognitive Assessment (MOCA)
Time frame: 6 months (after hospital discharge)
Percentage of patients requiring permanent cerebrospinal fluid (CSF) diversion due to hydrocephalus at 6 months
Time frame: 6 months
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
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
Incidence of delayed cerebral ischemia/vasospasm
Time frame: up to 14 days after aSAH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aditya Pandey, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deferoxamine in people with Aneurysmal Subarachnoid Hemorrhage, run by Aditya S. Pandey, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sravanthi Koduri (734-647-7960, skoduri@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility-weighted modified Rankin Scale (UW-mRS) at 6 months (time frame: 6 months (after hospital discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.