Intracerebral Hemorrhage (ICH) is the only stroke subtype without a clearly defined treatment. ICH occurs in over 100,000 Americans yearly, with 30% to 50% mortality and significant motor and cognitive disabilities in survivors. African-Americans, Hispanics and Asians are disproportionately affected. The long-term goal of this research is to change the way ICH is treated, that is, to reduce brain injury with an innovative combination of surgical and medical management. This proposal is a Phase II clinical trial with sufficient statistical power to provide a definitive evaluation of the safety of image-based, minimally invasive surgery (MIS) to aspirate clot followed by installations of rt-PA. Morbidity and mortality are directly related to the volume of blood clot and duration of blood exposure to the brain tissue. No trial has been organized to test the hypothesis that blood clot removal is safe. We will produce data regarding the capability of MIS with rt-PA to remove blood clot from ICH patients. The trial is in two steps: Dose Finding (successive dose tiers), followed by a Safety Study (randomized, controlled trial). The study will produce information critical to selecting the optimal dose of rt-PA. The results will provide first-time data about surgical safety, rt-PA clot dissolution and kinetics, patient selection, patient stability, treatment-related complications, and surgical safety. This study would demonstrate the first test of the relation between clot removal and outcome, and prepare the way for a successful Phase III trial to test the overall hypothesis that early and complete removal of ICH results in decreased morbidity and mortality.
Aim 1 (Stage 1: Dose-Finding Study): For patients with ICH treated with MIS, we will evaluate if increasing the total daily dose of rt-PA from 0.3 mg to 1.0 mg to 3.0 mg increases the rate of ICH blood clot dissolution.
Aim 2 (Stage 1: Dose-Finding Study and Stage 2: Safety Study): We will test the safety of intraclot catheter placement and aspiration of hematoma contents, followed by clot irrigation with low dose rt-PA. The goal is to achieve near total clot dissolution without procedure-related mortality, bleeding or infection rates greater than the rates of these events in patients managed with aggressive medical treatment.
Aim 3 (Stage 2: Safety Study): We will assess if MIS plus thrombolysis improves clot size dissolution in the surgical treatment group compared to clot size dissolution in the conventional medical treatment group. ? ?
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