Status:
WITHDRAWN
MIS Hematoma Evacuation
Lead Sponsor:
Lahey Clinic
Conditions:
Intracranial Hematoma
Eligibility:
All Genders
18-80 years
Brief Summary
The primary objective of this study is to determine the effectiveness of the NICO BrainPath™ hematoma evacuation system for patients between the ages of 18 and 80 years old with an intracerebral hemat...
Detailed Description
Approximately 100 patients will participate in this study. Patients with significant intraparenchymal hemorrhage who are admitted under the neurology service in the Neurocritical Care and Medical ICU ...
Eligibility Criteria
Inclusion
- 18 and 80 years of age, inclusive
- Spontaneous supratentorial, intracerebral hematoma ICH \>30 ml measured by the ABC/2 method.
- Location of Hemorrhage: Lobar, Putaminal and/or Caudate
- A Glasgow Coma Scale (GCS) of 4 or greater
- Historical Modified Rankin Score (mRS) of 0 (no symptoms of neurological disability) or 1 (no significant disability despite symptoms, able to carry out usual duties and activities).
Exclusion
- Pupils dilated and fixed
- Rapidly deteriorating patient (at the discretion of the surgeon)
- Primary Thalamic Bleed
- Intraventricular Blood (more than 50 % of either ventricle, visual estimate)
- ICH secondary to aneurysm
- Arteriovenous malformation (AVM)
- Tumor
- Moya-Moya
- Sinus thrombosis
- Platelet count \<100,000, INR \>1.4
- Known coagulopathy, on anticoagulants that cannot be reversed
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04466553
Start Date
October 1 2021
End Date
August 1 2022
Last Update
December 16 2021
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