Sildenafil for Prevention of Cerebral Vasospasm

Hospital de Clinicas de Porto Alegre

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Conditions

Subarachnoid Hemorrhage Cerebral Vasospasm Rupture of Intracranial Aneurysm

Interventions

PlaceboDRUG

Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.

Sildenafil Citrate, 25 mg, 3 times a day.DRUG

Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

Sildenafil Citrate 50 mg, 3 times a dayDRUG

Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

New neurological Deficit

Development of clinical symptoms suggestive of vasospasm, which are: afasia, hemiparesis, disorientation, or worsening of consciousness without hydrocephalus or expanding cloth. To access level of consciousness we will use the Glasgow Coma Scale.

Time frame: From third to 14th day post subarachnoid hemorrhage

Secondary Outcomes

Transcranial Ecodoppler

Signs of vasospasm in in transcranial ecodoppler.

Time frame: From the third to the 14th day after subarachnoid hemorrhage

Mortality

General mortality (for any causes).

Time frame: From the third to the 14th day before subarachnoid hemorrhage.

Side effects

Drug side effect: hypotension, visual blurring, nasal congestion, angina pectoris, asthma crisis, AV block, digestive bleeding, and priapism.

Time frame: From the third to the 14th day after subarachnoid hemorrhage.

Time to discharge

Time to discharge (period of hospital stay).

Time frame: From the third day after subarachnoid hemorrhage to discharge.

Rankin Scale

Modified Rankin scale at discharge.

Time frame: At discharge from the hospital.

Data from ClinicalTrials.gov

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