MINUTE is a prospective, multi-center, randomized, controlled, blinded assessor, adaptive enrichment design, clinical trial. Eligible patients with spontaneous BGH ≥20 mL will be randomized 1:1 to either minimally invasive endoscopic SCUBA evacuation plus standard medical management or standard medical management alone; the time of randomization will be used to classify participants in one of two cohorts: 1) those randomized \<8 hours from onset, and 2) those randomized 8-16 hours from onset. Randomization is targeted to occur within 120 min of arrival to the randomizing center's Emergency Department (ED), and initiation of surgery is targeted to occur within 120 min of randomization. Participants will be followed at 30, 90, 180, and 365 days to assess for adverse events (AEs) and utility-weighted modified Rankin Scale (UW-mRS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
The intervention is minimally invasive endoscopic ICH evacuation using the SCUBA approach29. Stereotactic guidance must be used to guide placement of the sheath into the hematoma. Using stereotactic guidance software, a trajectory is planned along the long axis of the hematoma to the skull while avoiding eloquent brain regions, prominent vasculature, and other anatomy that should not be traversed during the approach, such as the frontal sinuses. A tele-proctor will be available to review the trajectory prior to the procedure starting. The procedure is performed under general anesthesia. The patient's head can be fixed if required depending on the stereotactic navigation system used.
Participating physicians will attest that they will manage all ICH patients in the medical and surgical arms of the trial according to their institutional standards of care, which they will attest are consistent with the American Stroke Association guidelines for management of spontaneous ICH66 and utilize a standardized blood pressure management and hydrocephalus management protocol.
Banner University Medical Center - Phoenix
Phoenix, Arizona, United States
NOT_YET_RECRUITINGMayo Clinic
Phoenix, Arizona, United States
NOT_YET_RECRUITINGBanner University Medical Center - Tucson Campus
Tucson, Arizona, United States
NOT_YET_RECRUITINGKeck Hospital of USC
Los Angeles, California, United States
NOT_YET_RECRUITINGUtility-Weighted Modified Rankin Scale (UW-mRS)
Utility-Weighted Modified Rankin Scale (UW-mRS), a tool used primarily in stroke research to measure a patient's disability. It assigns a "utility" value (representing quality of life) to each level of the standard Modified Rankin Scale (mRS) to provide a more nuanced, patient-centered outcome measure than the mRS alone. The utility weighted mRS scales the 0-6 mRS range onto a 0-1 range, with higher scores indicating better health outcomes.
Time frame: Day 180
Mortality (all-cause)
Number of mortalities, for any reason, at day 30
Time frame: Day 30
Number of successful endoscopic clot removal
Successful endoscopic clot removal to ≤10 mL remaining clot
Time frame: during procedure
Volume of clot remaining post endoscopic clot removal
Volume of clot remaining on follow-up 24-hour CT scan post endoscopic clot removal
Time frame: 24 hours post procedure
Number of post-procedural complications adverse events
Symptomatic rebleeding into the cavitary lesion after evacuation resulting in residual hematoma volume \>10 mL and worsening of neurological status (defined as an increase in pre-evacuation NIHSS ≥4 points or a decrease in GCS ≥2 points which cannot be attributed to any other cause such as infection, seizures, sedation, or worsening edema) within 30 days.
Time frame: up to 30 days
Number of CNS infection
CNS infection attributed to surgery
Time frame: Day 30
Peri-cavity edema (PCE)
PCE on the 24-hour CT scan
Time frame: 24 hour
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Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGRonald Reagan UCLA Medical Center
Los Angeles, California, United States
RECRUITINGUC Davis Medical Center
Sacramento, California, United States
NOT_YET_RECRUITINGJohn Muir Medical Center - Walnut Creek Campus
Walnut Creek, California, United States
NOT_YET_RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGJackson Memorial Hospital
Miami, Florida, United States
NOT_YET_RECRUITING...and 34 more locations