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| ID | Type | Description | Link |
|---|---|---|---|
| 09453 | Other Identifier | Etics Comitee of Hospital de Clínicas de Porto Alegre |
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Absence of inclusion criteria
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo: soluble blue pigment | Placebo Comparator | Soluble blue pigment for placebo controlling. |
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| Sildenafil, 75mg daily | Experimental | Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage. |
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| Sildenafil, 150 mg daily | Experimental | Sildenafil citrate, 150 mg daily divided in 3 doses from third to 14th day after subarachnoid hemorrhage. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From third to 14th day post subarachnoid hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Transcranial Ecodoppler | Signs of vasospasm in in transcranial ecodoppler. | From the third to the 14th day after subarachnoid hemorrhage |
| Mortality | General mortality (for any causes). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André Cerutti Franciscatto, MD | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Marco Antônio Stefani, DR | Hospital de Clínicas de Porto Alegre | Study Director |
| Ápio Martins Antunes, DR | Hospital de Clínicas de Porto Alegre | Study Chair |
| Thiago Torres de Ávila, MD | Hospital de Clínicas de Porto Alegre | Study Chair |
| Mateus Lasta Beck, MD | Hospital de Clínicas de Porto Alegre | Study Chair |
| Mateus Franzói, MD | Hospital de Clínicas de Porto Alegre | Study Chair |
| Atahualpa Caue Strapasson, MD | Hospital de Clínicas de Porto Alegre | Study Chair |
| Sílvia Brustolin, DR | Hospital de Clínicas de Porto Alegre | Study Chair |
| Fabiane Backes, MD | Hospital de Clínicas de Porto Alegre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035903 | Brazil |
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| Label | URL |
|---|---|
| Official Site of Hospital de Clínicas de Porto Alegre | View source |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D020301 | Vasospasm, Intracranial |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| 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. |
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| Sildenafil Citrate 50 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. |
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| 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. | From the third to the 14th day after subarachnoid hemorrhage. |
| Time to discharge | Time to discharge (period of hospital stay). | From the third day after subarachnoid hemorrhage to discharge. |
| Rankin Scale | Modified Rankin scale at discharge. | At discharge from the hospital. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |