Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

Study Overview
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Brief Summary
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The investigators will test the central hypothesis that DFO treatment after SAH may improve cerebrovascular regulation, mitigate ischemic neural injury, and serve as an effective neuroprotectant against delayed ischemic injury after SAH.

Official Title
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Deferoxamine: An Emerging Therapy to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage

Conditions
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Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: desferrioxamine (DFO)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of spontaneous SAH impaired cerebral autoregulation on day 2-4 post SAH Exclusion Criteria: traumatic SAH other central neurological disorders such as tumors, known prior stroke, hemorrhage or vascular malformations pregnancy severe renal disease or anuria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desferrioxamine (DFO)<br>DFO (20mg/kg/hr) in normal saline IV for 4 hours for 5 consecutive days | Drug: desferrioxamine (DFO)<br>* DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days<br>* Other names: deferoxamine, desferal, DFO, deferoxamine mesylate;|
| Placebo Comparator: placebo<br>normal saline IV for 4 hours for 5 consecutive days | Drug: placebo<br>* normal saline IV for 4 hours for 5 consecutive days<br>* Other names: normal saline NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delayed cerebral ischemia (DCI) | DCI will be defined radiographically as any cerebral infarct on the latest CT scan that was seen within 6 weeks after SAH or before discharge or death, that was not present on admission scan or on the CT scan done within 24 to 48 hours after any aneurysmal treatment procedures. All head CT scans will be reviewed for DCI ascertainment by neuroradiologists blinded to the clinical and TCD data using the standardized protocol. | 6 weeks post hemorrhage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome at discharge | Clinical outcome at discharge will be assessed using modified Rankin Scale (mRS) as a global functional status. The modified Rankin scale evaluates global disability and handicap; scores range from 0 (no symptoms or disability) to 6 (death). Good mRS will be defined as score of ≤ 2. | patient's discharge date, which averages 3-4 weeks post hemorrhage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subarachnoid hemorrhage, SAH, DFO, cerebral autoregulation, delayed cerebral ischemia