Sildenafil for Prevention of Cerebral Vasospasm

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A Randomized Clinical Trial with security and dose testing of Sildenafil Citrate in patients with subarachnoid hemorrhage due to a rupture of a cerebral aneurism for prevention of cerebral vasospasm. The cerebral vasospasm is a decrease in blood flow that occurs when the intracranial vessels lose their capability of self-control of dilations and contractions. Patients with subarachnoid hemorrhage without neurological deficits who underwent endovascular or surgical correction of the aneurysm can participate in this trial. They will be randomized to a daily doses of 75 mg of Sildenafil, 150 mg of Sildenafil or Placebo from the third to the 14th day post bleeding. Today there is no proven clinical treatment for prevention of cerebral vasospasm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Citric Acid; Sildenafil Citrate; Sodium Citrate

Criteria

Inclusion Criteria:

• Males and females between 20 and 80 years old

• Subarachnoid hemorrhage confirmed by CT with Fisher III or IV criteria (blood in cisterns larger than 1 mm with or without blood in the ventricular system).

• Aneurysm detected in the conventional angiography, or angio-CT or angio - MRI.

• Patient underwent surgery for clipping or endovascular treatment in the first 72 hours after the ictus.

• Consent form signed by the patient or legal responsible.

Exclusion Criteria:

• Patient (or legal responsible) refuses to participate.

• Impossibility to collect consent form.

• Hemodynamical instability.

• Previous cardiac ischemic disease.

• History of cardiac arrhythmia within the last 6 months.

• History of Retinitis Pigmentosa.

• Previous use of drugs witch can interact with sildenafil (specially nitrates).

• Pregnancy.

• Known hypersensibility to Sildenafil.