Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation

Completed · Phase 2

Conditions studied: Intracerebral Hemorrhage

In brief

The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.

Key facts

Study ID

NCT00224770

Run by

Daniel Hanley

People needed

141

Starts

2005-08-01

Expected to finish

2013-04-01

Last updated by the study team

2015-06-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80
• GCS < 14 or a NIHSS > or equal to 6
• Spontaneous supratentorial ICH > or equal to 20cc
• Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom onset is exclusionary)
• Intention to initiate surgery within 48 hours after diagnostic CT
• First dose can be given within 54 hours after diagnostic CT (delays for post surgical stabilization of catheter bleeding or because of unanticipated surgical delay are acceptable with approved waiver from the coordinating center) (Does not apply to ICES Tier)
• Six-hour clot size equal to the most previous clot size + 5 cc (as determined by an additional CT scan at least 6 hours after the initial stability scan (A*B*C)/2 method)
• SBP < 200 mmHg sustained for 6 hours recorded closest to time of randomization
• Historical Rankin score of 0 or 1
• Negative pregnancy test

You may not qualify if…

• Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy)
• Patients with platelet count < 100,000, INR > 1.4, or an elevated PT or APTT (reversal of coumadin is permitted but the patient must not require coumadin during the acute hospitalization). Irreversible coagulopathy either due to medical condition or prior to randomization
• Clotting disorders
• Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease
• Patients with a mechanical valve
• Patients with unstable mass or evolving intracranial compartment syndrome
• Ruptured aneurysm, AVM, vascular anomaly
• Greater than 80 years (higher incidence of amyloid)
• Under 18 years of ag e (high incidence of occult vascular malformation)
• Pregnant (positive pregnancy test) or lactating females (likelihood of altered coagulation function associated with the high estrogen/progesterone state)
• Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS less than or equal to 4
• Historical Rankin score greater than or equal to 2
• Intraventricular hemorrhage requiring external ventricular drainage
• Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts (Does not apply to ICES Tier)
• Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention (Does not apply to ICES Tier)
• Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis (Does not apply to ICES Tier)
• In the investigator's opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus MIS+rtPA
• Prior enrollment in the study
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous trial of ICH treatment.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Barrow Neurosurgical Associates — Phoenix, Arizona, United States
• University of California Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California, San Diego — San Diego, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Rush University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• University of Maryland Medical Systems — Baltimore, Maryland, United States
• Johns Hopkins University/Bayview Medical Center — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• JFK Medical Center New Jersey — Edison, New Jersey, United States
• Mt. Sinai Medical Center — New York, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Case Western University — Cleveland, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas, Houston — Houston, Texas, United States
• University of Texas HSC, San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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