Endoscopic ICH Evacuation for Stroke

(MINUTE Trial)

Overseen By Sukaina Davdani

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Anticoagulants, Heparin

Disqualifiers: Coagulopathy, Infection, Pregnancy, Dementia, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new potential treatment for individuals who have experienced a spontaneous intracerebral hemorrhage (ICH), which involves sudden brain bleeding. Researchers aim to determine if combining a minimally invasive surgery called endoscopic ICH evacuation with standard medical treatment is more effective than standard treatment alone. Individuals who have had a spontaneous ICH with a blood clot size of 20 mL or more and can begin treatment within 16 hours of the stroke may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future stroke treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using certain blood thinners at the time of stroke onset. It's best to discuss your specific medications with the trial team.

What prior data suggests that this endoscopic ICH evacuation is safe?

Research has shown that endoscopic intracerebral hemorrhage (ICH) evacuation is generally well-tolerated. In one study, about 10.4% of patients who underwent this procedure died within a month, which was lower than the expected rate of 35.1%. Another study found a 30% mortality rate, similar to other endoscopic procedures.

While there are risks, with about 60% of patients experiencing complications after the procedure, these issues are common in surgeries of this nature.

Overall, the procedure appears to be a safer option compared to some traditional methods, with a lower than expected death rate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Endoscopic ICH Evacuation because it offers a minimally invasive approach to treating strokes caused by intracerebral hemorrhage (ICH). Unlike traditional surgical methods, which can be more invasive and risky, this technique uses advanced endoscopic tools to precisely remove blood clots, potentially reducing damage to surrounding brain tissue. This innovative method aims to improve recovery times and outcomes for stroke patients, offering hope for a quicker and safer recovery compared to standard medical treatments alone.

What evidence suggests that endoscopic ICH evacuation is effective for stroke?

Research has shown that endoscopic ICH evacuation, a procedure participants in this trial may receive, can effectively treat strokes with heavy bleeding. This minimally invasive surgery can remove about 88.2% of the blood clot, leaving only a small amount behind. One study suggested that using a method called SCUBA for ICH may reduce the risk of death within 30 days. Some evidence also indicates that this procedure can help decrease brain swelling caused by bleeding. However, uncertainty remains about whether this surgery leads to better long-term recovery compared to medication, the standard medical treatment arm in this trial. ^{2 3 4 5 6}

Who Is on the Research Team?

Magdy Selim, MD, PhD

Principal Investigator

Harvard Medical School (HMS and HSDM)

J Mocco, MD

Principal Investigator

Mount Sinai Hospital System

Sharon Yeatts, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for stroke patients with a specific type of bleeding in the brain (spontaneous BGH ≥20 mL). They must be able to undergo surgery within 8-16 hours from symptom onset. The trial excludes certain individuals, but those details are not provided here.

Inclusion Criteria

NIHSS ≥ 6 at presentation

Computed Tomography Angiography (CTA) or Magnetic Resonance Angiography (MRA) is performed and does not show an underlying vascular lesion

Pre-ICH mRS 0-2 Informed consent from patient or legally authorized representative (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)

Exclusion Criteria

Coagulopathy defined as international normalized ratio (INR) > 1.4

Elevated activated Partial Thromboplastin Time (aPTT) > 40 s

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participants are randomized to either minimally invasive endoscopic SCUBA evacuation plus standard medical management or standard medical management alone. Surgery is initiated within 120 minutes of randomization.

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and utility-weighted modified Rankin Scale (UW-mRS) at 30, 90, 180, and 365 days.

365 days

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic ICH Evacuation

Trial Overview The MINUTE trial tests if using a minimally invasive endoscopic technique to remove blood from the brain, along with standard care, improves outcomes compared to standard care alone. Patients are grouped by how soon they receive treatment after arriving at the hospital.

How Is the Trial Designed?

Group I: Endoscopic ICH evacuation (SCUBA) and Standard Medical Treatment Experimental Treatment 2 Interventions

Participants will be treated with SCUBA and Standard Medical Treatment

Group II: Standard Medical Treatment Placebo Group 1 Intervention

Participants will be treated with Standard Medical Treatment

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

NINDS Stroke Trials Network (StrokeNet)

Collaborator

Trials

2

Recruited

1,600+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39425219/

Early minimally invasive image-guided endoscopic ... The aim of this trial is to compare whether early minimally invasive endoscopic surgery leads to improved functional outcome rates compared to the best medical ...

2. jnis.bmj.com jnis.bmj.com/content/12/5/489

Long-term functional outcome following minimally invasive ... This procedure was found to be effective with an average evacuation percentage of 88.2% and mean postoperative hematoma volume of 6.2 mL. Eighty-six percent of ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.121.032238?doi=10.1161/STROKEAHA.121.032238

Surgical Evacuation of Intracerebral Hemorrhage | Stroke Minimally invasive ICH evacuation has been shown to partially mitigate PHE. Data from phase 2 of the MISTIE trial demonstrated a significant ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875022001371

Stereotactic IntraCerebral Underwater Blood Aspiration ... This study suggests that minimally invasive hematoma evacuation with the SCUBA technique for ICH may reduce predicted 30-day mortality.

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2838201

Minimally Invasive Surgery vs Medical Management Alone ... It remains uncertain whether surgical evacuation improves functional outcomes in patients with supratentorial intracerebral hemorrhage (ICH).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11611861/

Early minimally invasive image-guided eNdoscopic ... We report three deaths (30%) and six adverse events (60%). The mortality rate is comparable to the current literature described for endoscopic ...