ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)

Completed · Not applicable

Conditions studied: Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracerebral Haemorrhage

In brief

This is a multicenter, randomized, adaptive clinical trial comparing standard medical management to early (\<24 hours) surgical hematoma evacuation using minimally invasive parafascicular surgery (MIPS) in the treatment of acute spontaneous supratentorial intracerebral hemorrhage.

Key facts

Study ID

NCT02880878

Run by

Nico Corporation

People needed

300

Starts

2016-12-01

Expected to finish

2023-02-01

Last updated by the study team

2023-05-10

Who can join

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

You may qualify if…

• Age 18-80 years
• Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH
• ICH volume between 30 - 80 mL
• Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. If the actual time of onset is unclear, then the onset will be considered the time that the subject was last known to be well
• Glasgow Coma Score (GCS) 5 - 14
• Historical Modified Rankin Score 0 or 1

You may not qualify if…

• Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (<1 year) ICH, as diagnosed with radiographic imaging
• NIHSS < 5
• Bilateral fixed dilated pupils
• Extensor motor posturing
• Intraventricular extension of the hemorrhage is visually estimated to involve >50% of either of the lateral ventricles
• Primary Thalamic ICH
• Infratentorial intraparenchymal hemorrhage including midbrain, pontine, or cerebellar
• Use of anticoagulants that cannot be rapidly reversed
• Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
• Uncorrected coagulopathy or known clotting disorder
• Platelet count < 75,000, International Normalized Ratio (INR) > 1.4 after correction
• Patients requiring long-term anti-coagulation that needs to be initiated < 5 days from index ICH
• End stage renal disease
• Patients with a mechanical heart valve
• End-stage liver disease
• History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal
• Known life-expectancy of less than 6 months
• No reasonable expectation of recovery, Do-Not-Resuscitate (DNR), or comfort measures only prior to randomization
• Participation in a concurrent interventional medical investigation or clinical trial.
• Inability or unwillingness of subject or legal guardian/representative to give written informed consent
• Homelessness or inability to meet follow up requirements

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Barrow Neurological Institute (BNI) — Phoenix, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• University of Southern California (USC) — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Baptist Health Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Miami / Jackson Memorial Hospital — Miami, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• St. Vincent Indianapolis — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University (Barnes Jewish) — St Louis, Missouri, United States
• Cooper University Health Care — Camden, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• State University of New York, Buffalo — Buffalo, New York, United States
• New York Presbyterian Queens — Flushing, New York, United States
• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.