Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation

ID#: NCT07260916

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: July 15, 2026

End Date: June 30, 2030

Contact Information:
Ally Qi, MPH
209-330-3024
Cynthia Nguyen, MsCR
Summary: 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:

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years

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

3. NIHSS ≥ 6 at presentation

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

5. Pre-ICH mRS 0-2

6. Informed consent from patient or LAR to participate in the trial, wherein patient/LAR's stated wishes are to pursue lifesaving therapies as opposed to early withdrawal of care (explicitly explained as <7 days following ictus)

7. The treating physician anticipates that surgery can be initiated <120 min from randomization

8. Randomization within 16 hours from LKW and within 2 hours of arrival to the randomizing center.

Exclusion Criteria:

1. 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

2. Infratentorial or thalamic hemorrhage

3. Midbrain extension/involvement

4. Coagulopathy defined as international normalized ratio (INR) > 1.4

5. Elevated activated Partial Thromboplastin Time (aPTT) > 40 s

6. Concurrent use of direct oral anticoagulants or low molecular weight heparin at ICH onset

7. Known hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency

8. Platelet count <100 x 103 cells/mm3, or known platelet dysfunction (reversal of coagulopathy is not allowed)

9. GCS score <7 at presentation

10. Evidence of active infection indicated by fever ≥100.7 °F and/or open draining wound at the time of enrollment

11. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 365 days

12. Intraventricular extension of the hemorrhage is visually estimated to involve > 50% of either of the lateral ventricles

13. Pregnancy (women of childbearing potential must have a negative pregnancy test to participate)

14. Based on investigator's judgment, the patient does not have the necessary mental capacity to participate or is unwilling to comply with the protocol follow-up schedule

15. Current participation in another interventional (drug or device) trial

16. Pre-existing Do Not Resuscitate (DNR)/Do Not Intubate (DNI) status

17. History of severe dementia
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