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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3NS138638-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Beth Israel Deaconess Medical Center | OTHER |
| Medical University of South Carolina | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment | Experimental | Participants will be treated with SCUBA and Standard Medical Treatment |
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| Standard Medical Treatment | Placebo Comparator | Participants will be treated with Standard Medical Treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ICH evacuation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Utility-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. | Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of successful endoscopic clot removal | Successful endoscopic clot removal to ≤10 mL remaining clot | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ally Qi, MPH | Contact | 2093303024 | ally.qi@mountsinai.org | |
| Sukaina Davdani | Contact | sukaina.davdani@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| J Mocco, MD | Mount Sinai Hospital System | Principal Investigator |
| Magdy Selim, MD, PhD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Sharon Yeatts, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | Recruiting | New Brunswick | New Jersey | 08901 | United States |
Individual participant data that underlie the results reported in this article, after deidentification.
Will follow StrokeNet and NIH data sharing guidelines
Submission of (and subsequent approval of) request for use to the appropriate repository.
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| NINDS Stroke Trials Network (StrokeNet) |
| OTHER |
Adult patients (18-80 years old) with spontaneous Basal Ganglia (BG) intracerebral hemorrhage (ICH) ≥20 mL able to be randomized for endoscopic evacuation within 16 hours of ICH onset or last known well (LKW). Endoscopic minimally invasive Stereotactic Cerebral Underwater Blood Aspiration (SCUBA) of spontaneous basal ganglia ICH (BGH)
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MINUTE is an on-label study with a blinded end-point outcome assessment, i.e. participants, providers, and site investigators will not be blinded to treatment assignments. Blinding is difficult, if not impossible, from a clinical perspective. It is not possible to blind the Investigator who treats the patient, the clinical staff, or the research team. Physicians treating participants who experience an AE after must know how the hemorrhage was treated in order to effectively report the AE and plan further treatment. However, MINUTE will require that study-related follow-up assessments be conducted by blinded investigators certified in mRS assessment, who were not involved in clinical care of the participant and are unaware of the patient's randomization status. A large Band-Aid will be placed on every patient's forehead prior to blinded assessor review, thereby preventing scar visualization or misinterpretation of unrelated scars on control patients.
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| Standard Medical Treatment | Other | 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. |
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| 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. | up to 30 days |
| Number of CNS infection | CNS infection attributed to surgery | Day 30 |
| Mortality (all-cause) | Number of mortalities, for any reason, at day 30 | Day 30 |
| Medical University of South Carolina |
| Principal Investigator |
| Mount Sinai Health System | Recruiting | New York | New York | 10029 | United States |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |