Sildenafil for Prevention of Cerebral Vasospasm
- Conditions
- Rupture of Intracranial AneurysmSubarachnoid HemorrhageCerebral Vasospasm
- Interventions
- Registration Number
- NCT01091870
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sildenafil, 75mg daily Sildenafil Citrate, 25 mg, 3 times a day. Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage. Placebo: soluble blue pigment Placebo Soluble blue pigment for placebo controlling. Sildenafil, 150 mg daily Sildenafil Citrate 50 mg, 3 times a day Sildenafil citrate, 150 mg daily divided in 3 doses from third to 14th day after subarachnoid hemorrhage.
- Primary Outcome Measures
Name Time Method New neurological Deficit From third to 14th day post subarachnoid hemorrhage 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.
- Secondary Outcome Measures
Name Time Method Transcranial Ecodoppler From the third to the 14th day after subarachnoid hemorrhage Signs of vasospasm in in transcranial ecodoppler.
Mortality From the third to the 14th day before subarachnoid hemorrhage. General mortality (for any causes).
Side effects From the third to the 14th day after subarachnoid hemorrhage. Drug side effect: hypotension, visual blurring, nasal congestion, angina pectoris, asthma crisis, AV block, digestive bleeding, and priapism.
Time to discharge From the third day after subarachnoid hemorrhage to discharge. Time to discharge (period of hospital stay).
Rankin Scale At discharge from the hospital. Modified Rankin scale at discharge.
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil