Health TrialsbyHealthPanel

Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

ConditionBasal Ganglia Intracerebral Hemorrhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWeill Medical College of Cornell University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and ≤ 80 years

Non-traumatic, spontaneous, supratentorial, non-thalamic, BGH of volume ≥ 20 mL, as determined by the treating physician using ABC/2 method

NIHSS ≥ 6 at presentation

CTA or MRA is performed and does not show an underlying vascular lesion

Disqualifiers

Suspected secondary cause for the ICH, such as an underlying vascular malformation (cavernous malformation, arteriovenous malformation, etc.), aneurysm, neoplasm, hemorrhagic transformation of an underlying ischemic infarct; or venous infarct

Infratentorial or thalamic hemorrhage

Midbrain extension/involvement

Coagulopathy defined as international normalized ratio (INR) > 1.4

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic ICH evacuation

    Procedure/Surgery

    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.

  • Standard Medical Treatment

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Endoscopic ICH evacuation (SCUBA) and Standard Medical TreatmentExperimental treatment 2 interventions
Group B: Standard Medical TreatmentPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 180
2

Mortality (all-cause)

Number of mortalities, for any reason, at day 30

Time frame
Day 30

Secondary outcomes

1

Number of successful endoscopic clot removal

Successful endoscopic clot removal to ≤10 mL remaining clot

Time frame
during procedure
2

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
3

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
4

Number of CNS infection

CNS infection attributed to surgery

Time frame
Day 30

Other outcomes

Sponsors and contacts

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Weill Medical College of Cornell University

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Beth Israel Deaconess Medical Center

Collaborator

Medical University of South Carolina

Collaborator

NINDS Stroke Trials Network (StrokeNet)

Collaborator

Source ClinicalTrials.gov
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