Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
(MISTIE-III Trial)

Recruiting in Palo Alto (17 mi)

+83 other locations

Overseen byIssam Awad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).

Research Team

Mario Zuccarello, MD

Principal Investigator

University of Cincinnati

Issam Awad, MD

Principal Investigator

University of Chicago

Daniel F. Hanley, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging (computerized tomography (CT), computerized tomography angiography (CTA), etc.), with a Glasgow Coma Scale (GCS) ≤ 14 or a NIHSS ≥ 6.

Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth < 5 mL as measured by ABC/2 method).

Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary).

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Treatment Details

Interventions

rt-PA (Thrombolytic Agent)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: MIS plus rt-PA managementExperimental Treatment1 Intervention

Subjects randomized to the Minimally Invasive Surgery (MIS) plus rt-PA management arm will undergo minimally invasive surgery followed by up to 9 doses of 1.0 mg of rt-PA (Activase/Alteplase/CathFlo) for intracerebral hemorrhage clot resolution.

Group II: Medical managementActive Control1 Intervention

Subjects randomized to medical management will receive the standard medical therapies for the treatment of intracerebral hemorrhage, which includes ICU care only and no planned surgical intervention.