Subarachnoid Hemorrhage
Conditions
Keywords
subarachnoid hemorrhage, SAH, DFO, cerebral autoregulation, delayed cerebral ischemia
Brief summary
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.
Interventions
DRUGdesferrioxamine (DFO)
DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days
DRUGplacebo
normal saline IV for 4 hours for 5 consecutive days
Sponsors
Dr. Jeffrey Thomas Stroke Shield Foundation
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| delayed cerebral ischemia (DCI) | 6 weeks post hemorrhage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome at discharge | patient's discharge date, which averages 3-4 weeks post hemorrhage | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cerebrovascular function (i.e., cerebral autoregulation) | 5 days after initiation of study drug | Spectral analysis of the relationship between arterial pressure and blood flow velocity in the bilateral middle cerebral arteries (measured via TCD). Autoregulation will be assessed from the phase and gain of the transfer function. Phase shift reflects the temporal difference between cerebral flow velocity fluctuations with respect to arterial pressure fluctuations. When the fluctuations of both flow and pressure are almost synchronous, the phase shift approaches zero, reflecting impaired cerebral autoregulation. Transfer function gain reflects the magnitude of transmission of arterial pressure fluctuations to cerebral blood flow velocity fluctuations. Lower gain, particularly in the low frequency (\< 0.1 Hz) range, is reflective of more effective cerebral autoregulation. Coherence reflects the degree of linear dependence between pressure and flow fluctuations. Thus, it provides a measure of validity of the metrics (gain and phase) derived from the linear transfer function. |
Countries
United States
Outcome results
None listed