A Phase 2 interventional study of Placebo and Sildenafil Citrate, 25 mg, 3 times a day. in Subarachnoid Hemorrhage, Cerebral Vasospasm and Rupture of Intracranial Aneurysm, sponsored by Hospital de Clinicas de Porto Alegre. Withdrawn at 1 site in Brazil. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Hospital de Clinicas de Porto Alegre · Phase 2, Interventional, and Prevention
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.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
Browse Subarachnoid Hemorrhage studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Soluble blue pigment for placebo controlling.
Drug: Placebo
Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage.
Drug: Sildenafil Citrate, 25 mg, 3 times a day.
Sildenafil citrate, 150 mg daily divided in 3 doses from third to 14th day after subarachnoid hemorrhage.
Drug: Sildenafil Citrate 50 mg, 3 times a day
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 (TID)from the third to the 14 day after subarachnoid hemorrhage.
Also known as: Viagra
Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
Also known as: Viagra
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
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.
This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas de Porto Alegre