Health TrialsbyHealthPanel

Deferoxamine In the Treatment of Aneurysmal Subarachnoid Hemorrhage (aSAH)

ConditionAneurysmal Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAditya S. Pandey, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aneurysmal SAH confirmed with vascular imaging

Aneurysm treated with endovascular or microsurgical intervention

Hunt-Hess ≤ 4

Modified Fisher Grade I-IV

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Deferoxamine lower doseExperimental treatment 1 intervention
Group B: Deferoxamine higher doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months (after hospital discharge)

Secondary outcomes

1

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.

Time frame
At discharge from hospital (approximately 3-4 weeks)
2

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.

Time frame
6 months (after hospital discharge)
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)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aditya S. Pandey, MD

Lead sponsor

University of Michigan

Sponsor institution

Source ClinicalTrials.gov
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