Allegheny Health Network
Find a
Doctor
Request An Appointment Login to
MyChart
Patient
Center
News Classes &
Events
Contact
Us
Call 412.Doctors

Active Clinical Trials

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

Active NCT:
02880878
Allegheny General Hospital
Allegheny General Hospital

Category:
Brain and Nerve
Sponsor: 
Nico Corporation
Contact: 

For more information, please contact Dawn Skirpan at 412-359-4604 or Dawn.Skirpan@ahn.org.

ENRICH: A Multi-center, Randomized, Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery (MIPS) in the Treatment of Intracerebral Hemorrhage (ICH)

Purpose: 

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.

Ages Eligible for Study:  18 Years to 80 Years   (Adult, Senior)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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