Sildenafil for DCI
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 2/6/2019 |
| Start Date: | December 2016 |
| End Date: | July 2020 |
| Contact: | Chad W Washington, MS, MD, MPHS |
| Email: | cwashington4@umc.edu |
| Phone: | 601-984-5700 |
Sildenafil for the Treatment of Delayed Cerebral Ischemia Following Subarachnoid Hemorrhage
Each year, approximately 30,000 people in the United States suffer an intra-cranial
hemorrhage due to aneurysmal rupture. Of those surviving the initial event, up to 40% will go
on to have further neurological injury secondary to stroke (delayed cerebral ischemia) caused
by constriction of blood vessels (i.e. vasospasm). Previous studies have shown that the
medication sildenafil, given intravenously, improves vasospasm, but has an associated degree
of hypotension. The degree of hypotension was well within safety thresholds for these
patients.
Sildenafil is a medication that strongly inhibits the protein phosphodiesterase-V (PDE-V).
The hypothesis for this study is that oral sildenafil will also improve vasospasm, but does
not result in as much hypotension. Specifically, the investigators look to show that
comparable doses of oral sildenafil produces the same degree of PDE-V inhibition as an
intravenous dose while the degree of hypotension is reduced. Additionally, using measurements
of cerebral blood flow regulation acquired using transcranial Doppler ultrasound, the
investigators look to show that oral sildenafil produces the same degree of improvement in
vasospasm and blood flow regulation.
hemorrhage due to aneurysmal rupture. Of those surviving the initial event, up to 40% will go
on to have further neurological injury secondary to stroke (delayed cerebral ischemia) caused
by constriction of blood vessels (i.e. vasospasm). Previous studies have shown that the
medication sildenafil, given intravenously, improves vasospasm, but has an associated degree
of hypotension. The degree of hypotension was well within safety thresholds for these
patients.
Sildenafil is a medication that strongly inhibits the protein phosphodiesterase-V (PDE-V).
The hypothesis for this study is that oral sildenafil will also improve vasospasm, but does
not result in as much hypotension. Specifically, the investigators look to show that
comparable doses of oral sildenafil produces the same degree of PDE-V inhibition as an
intravenous dose while the degree of hypotension is reduced. Additionally, using measurements
of cerebral blood flow regulation acquired using transcranial Doppler ultrasound, the
investigators look to show that oral sildenafil produces the same degree of improvement in
vasospasm and blood flow regulation.
Inclusion Criteria:
1. Age >= 21
2. Onset of symptoms within 72 hours from presentation
3. Subarachnoid hemorrhage from ruptured cerebral aneurysm
4. Cerebral vasospasm diagnosed on transcranial doppler, CT angiography, or digital
subtraction angiography
Exclusion Criteria:
1. Pregnancy
2. Subarachnoid hemorrhage secondary to traumatic or mycotic aneurysm
3. Pre-ictal sildenafil therapy (last dose within 1 week of presentation)
4. Contraindications to sildenafil therapy (i.e. use of nitrates, left ventricular
outflow obstruction, impaired autonomic blood pressure control)
We found this trial at
1
site
2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
Phone: 601-984-5700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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