Cerebral Vasospasm, Rupture of Intracranial Aneurysm, Subarachnoid Hemorrhage
Conditions
Keywords
Aneurysm, Vasospasm, sildenafil, Viagra
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.
Interventions
DRUGPlacebo
Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.
DRUGSildenafil Citrate, 25 mg, 3 times a day.
Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
DRUGSildenafil Citrate 50 mg, 3 times a day
Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed