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

Sponsored by Nico Corporation

About this trial

Last updated 3 years ago

Study ID

DC-6010

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 80 Years
All Sexes

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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

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