Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
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J Stroke Cerebrovasc Dis · Jul 2011
Randomized Controlled Trial Multicenter StudyNeurosurgical outcomes after intracerebral hemorrhage: results of the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST).
The value of neurosurgical interventions after spontaneous intracerebral hemorrhage (SICH) is uncertain. We evaluated clinical outcomes in patients diagnosed with SICH within 3 hours of symptom onset who underwent hematoma evacuation or external ventricular drainage (EVD) of the hematoma in the Factor Seven for Acute Hemorrhagic Stroke Trial (FAST). FAST was a randomized, multicenter, double-blind, placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries. ⋯ ICH volume was substantially decreased in patients who underwent hematoma evacuation between 24 and 72 hours after hospital admission, and this was associated with better clinical outcome. In conclusion, a small number of patients who underwent neurosurgery in FAST exhibited no overall clinical benefit from neurosurgical intervention, although outcomes varied by type of surgery, time of surgery, and hematoma location. Our findings support the need for further research into the value of neurosurgery in patients with SICH.
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J Stroke Cerebrovasc Dis · Jul 2011
Randomized Controlled Trial Multicenter StudyCerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial.
No drug to treat vascular dementia (VaD) has yet been approved by the American or European authorities, leaving a large population of patients without effective therapy. Cerebrolysin has a long record of safety and might be efficacious in this condition. We conducted a large, multicenter, double-blind, placebo-controlled study in 242 patients meeting the criteria for VaD. ⋯ For Cerebrolysin, the odds ratio for achieving a favorable CIBIC+ response was 5.08 (P < .05), and that for achieving a favorable combined response was 5.63 (P < .05). Our data indicate that the addition of Cerebrolysin significantly improved clinical outcome, and that the benefits persisted for at least 24 weeks. Cerebrolysin was safe and well tolerated.
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J Stroke Cerebrovasc Dis · Jul 2011
Randomized Controlled Trial Multicenter StudyDesign of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial.
Patients with recent transient ischemic attack (TIA) or stroke caused by 70% to 99% stenosis of a major intracranial artery are at high risk of recurrent stroke on usual medical management, suggesting the need for alternative therapies for this disease. ⋯ This is the first randomized stroke prevention trial to compare angioplasty and stenting with medical therapy in patients with intracranial arterial stenosis and to incorporate intensive management of multiple risk factors and a lifestyle modification program in the study design. Hopefully, the results of the trial will lead to more effective therapy for this high-risk disease.