Kurzfassung

The purpose of this Phase III randomized clinical trial (RCT) is to compare a policy of early extraventricular drain (EVD) use and recombinant tissue plasminogen activator (rt-PA, Alteplase, Genentech, Inc., San Francisco, CA) with EVD use and placebo (normal saline) the treatment of subjects with intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) with obstruction of the 3rd or 4th ventricles by blood. We will evaluate a population of 500 ICH subjects with intraventricular...The purpose of this Phase III randomized clinical trial (RCT) is to compare a policy of early extraventricular drain (EVD) use and recombinant tissue plasminogen activator (rt-PA, Alteplase, Genentech, Inc., San Francisco, CA) with EVD use and placebo (normal saline) the treatment of subjects with intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) with obstruction of the 3rd or 4th ventricles by blood. We will evaluate a population of 500 ICH subjects with intraventricular hemorrhage, representative of current clinical practice and national demographics of ICH.

Primary Aim: To determine whether early EVD placement with low-dose rt-PA improves modified Rankin Scale scores at 6 months (dichotomized Rankin 0-3 vs. 4-6) compared to subjects treated with EVD placement and placebo.

Primary Hypothesis: Early EVD and treatment with low-dose rt-PA can increase the percent of patients with a good functional outcome, compared to treatment with EVD and placebo by a 15% absolute difference (expressed as an odds ratio of 1.8).» weiterlesen» einklappen