Sildenafil for Prevention of Cerebral Vasospasm Secondary to Subarachnoid Haemorrhage - Phase II Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- New neurological Deficit
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo: soluble blue pigment
Soluble blue pigment for placebo controlling.
干预措施: Placebo (Drug)
Sildenafil, 75mg daily
Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage.
干预措施: Sildenafil Citrate, 25 mg, 3 times a day. (Drug)
Sildenafil, 150 mg daily
Sildenafil citrate, 150 mg daily divided in 3 doses from third to 14th day after subarachnoid hemorrhage.
干预措施: Sildenafil Citrate 50 mg, 3 times a day (Drug)
结局指标
主要结局
New neurological Deficit
时间窗: 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.
次要结局
- Transcranial Ecodoppler(From the third to the 14th day after subarachnoid hemorrhage)
- Mortality(From the third to the 14th day before subarachnoid hemorrhage.)
- Side effects(From the third to the 14th day after subarachnoid hemorrhage.)
- Time to discharge(From the third day after subarachnoid hemorrhage to discharge.)
- Rankin Scale(At discharge from the hospital.)