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Phosphodiesterase-V Inhibitor

Low dose sildenafil citrate for Subarachnoid Hemorrhage

Phase 1

Waitlist Available

Led By Chad W Washington, MS, MD, MPHS

Research Sponsored by University of Mississippi Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 20, and 24 hours post-dose

Awards & highlights

Study Summary

This trial tests whether oral sildenafil is as effective as intravenous sildenafil in reducing vasospasm after aneurysmal rupture, while also causing less hypotension.

Eligible Conditions

Subarachnoid Hemorrhage
Cerebral Vasospasm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 20, and 24 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 20, and 24 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 20, and 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the plasma concentration versus time curve (AUC) of sildenafil

Systemic arterial pressure

Secondary outcome measures

Area under the cerebral spinal fluid concentration versus time curve (AUC) of sildenafil

Change from baseline in cerebral autoregulation

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low dose sildenafilExperimental Treatment1 Intervention

Twelve patients with cerebral vasospasm following aneurysmal subarachnoid hemorrhage will be assigned to low dose sildenafil citrate and will receive a 20mg oral dose and a subsequent 10mg intravenous dose of sildenafil citrate.

Group II: High dose sildenafilExperimental Treatment1 Intervention

Twelve patients with cerebral vasospasm following aneurysmal subarachnoid hemorrhage will be assigned to high dose sildenafil citrate and will receive a 60mg oral dose and a subsequent 30mg intravenous dose of sildenafil citrate.

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Who is running the clinical trial?

University of Mississippi Medical CenterLead Sponsor

173 Previous Clinical Trials

195,063 Total Patients Enrolled

Chad W Washington, MS, MD, MPHSPrincipal InvestigatorUniversity of Mississippi Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this trial?

"Unfortunately, this medical trial is not enrolling new patients at the moment. According to clinicaltrials.gov, which posted it on December 1st 2016 and last updated it on June 5th 2021, recruitment has been temporarily halted. However, there are 366 trials for subarachnoid hemorrhage actively recruiting participants and 23 studies related to Low dose sildenafil citrate currently admitting volunteers."

Answered by AI

Are there any opportunities to partake in this scientific experiment?

"According to the information hosted on clinicaltrials.gov, this specific trial is not recruiting participants at present. This research was initially posted in December 2016 and last updated in June 2021; nonetheless, there are a plethora of other studies that are currently seeking volunteers."

Answered by AI

What conditions can be treated with Low dose sildenafil citrate?

"Low dose sildenafil citrate has been demonstrated to be beneficial in treating premature ejaculation as well as NYHA Functional Class II-III Pulmonary Arterial Hypertension."

Answered by AI

What kind of safety profiles have been observed with the use of low-dose sildenafil citrate?

"While the efficacy of low dose sildenafil citrate remains largely unknown, prior data indicates that it is safe to use. Therefore, our team at Power gave this medication a score of 1 on their safety scale assessment."

Answered by AI

Recent research and studies

Journal of NeurosurgeryJournal

A Phase I Proof-of-concept and Safety Trial of Sildenafil to Treat Cerebral Vasospasm Following Subarachnoid Hemorrhage

Washington, Chad W., Colin P. Derdeyn, Rajat Dhar, Eric J. Arias, Michael R. Chicoine, DeWitte T. Cross, Ralph G. Dacey, et al.. 2016. “A Phase I Proof-of-concept and Safety Trial of Sildenafil to Treat Cerebral Vasospasm Following Subarachnoid Hemorrhage”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/2015.2.jns142752.

Neurocritical CareJournal

Acute Effect of Intravenous Sildenafil on Cerebral Blood Flow in Patients with Vasospasm After Subarachnoid Hemorrhage

Dhar, Rajat, Chad Washington, Michael Diringer, Allyson Zazulia, Hussain Jafri, Colin Derdeyn, and Gregory Zipfel. 2016. “Acute Effect of Intravenous Sildenafil on Cerebral Blood Flow in Patients with Vasospasm After Subarachnoid Hemorrhage”. Neurocritical Care. Springer Science and Business Media LLC. doi:10.1007/s12028-016-0243-0.

Journal of NeurosurgeryJournal

A Phase I Proof-of-concept and Safety Trial of Sildenafil to Treat Cerebral Vasospasm Following Subarachnoid Hemorrhage

clinicaltrials.govStudy

Sildenafil for DCI