Intracerebral Hemorrhage Clinical Trial
Official title:
Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.
The purpose of this trial is to determine the safety of using a combination of minimally
invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The
procedure is to use image-based surgery (MRI or CT) to provide catheter access to ICH for
the intervention, which is a one-time clot aspiration followed by instillation of rt-PA over
72 hours.
The Intraoperative stereotactic CT-guided Endoscopic Surgery (ICES) arm of the trial will
determine the safety, feasibility and effectiveness of endoscopic surgery to remove ICH.
This tests the first step of the MISTIE surgical procedure with an endoscope, not a rigid
cannula.
We propose to test if these interventions facilitate more rapid and complete recovery of
function and decreased mortality from this condition compared to conventional medical
management without subjecting the patient to craniotomy. The specific objective of this
trial is to test the safety of these interventions and assess their ability to remove blood
clot from brain tissue.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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