ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH) (ENRICH)
Intracerebral Hemorrhage, Cerebral Hemorrhage, Intracerebral Haemorrhage
About this trial
This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Subcortical Intracerebral Hemorrhage, Intracerebral Hemorrhage, Intracranial Hemorrhages, ICH, Hemorrhage, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Pathologic Processes, MIPS, Minimally Invasive Parafascicular Surgery, Neurosurgery, Medical Economic, Hospital Economics
Eligibility Criteria
Inclusion Criteria:
- Age 18-80 years
- Pre-randomization head CT demonstrating an acute, spontaneous, primary ICH
- Manual 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Alabama at Birmingham
- Barrow Neurological Institute (BNI)
- University of Arkansas for Medical Sciences
- University of Southern California (USC)
- Cedars-Sinai Medical Center
- Delray Medical Center
- Baptist Health Jacksonville
- Mayo Clinic
- University of Miami / Jackson Memorial Hospital
- Emory University School of Medicine
- Rush University Medical Center
- NorthShore University Health System
- OSF Saint Francis Medical Center
- Indiana University
- St. Vincent Indianapolis
- Johns Hopkins University
- Brigham and Women's Hospital
- Spectrum Health
- Saint Louis University
- Washington University (Barnes Jewish)
- Cooper University Health Care
- Albany Medical Center
- Montefiore
- State University of New York, Buffalo
- New York Presbyterian Queens
- Weill Cornell Medicine
- The University of North Carolina at Chapel Hill
- Cleveland Clinic Foundation
- Ohio State University Wexner Medical Center
- OhioHealth Riverside Methodist Hospital
- University of Oklahoma
- Geisinger Health System
- Penn State Hershey Medical Center
- Allegheny General Hospital
- University of Pittsburgh Medical Center (UPMC)
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Early Surgical Hematoma Evacuation
Medical Management
Subjects will receive early surgical hematoma evacuation using Minimally Invasive Parafascicular Surgery (MIPS).
Subjects will receive standard of care medical management for ICH.