Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
Completed
Conditions studied: Intracerebral Hemorrhage
In brief
This study is determining the clinical outcomes, based on neurological testing, for the parafascicular minimally invasive clot evacuation technique. We will collect data from the time of surgery up until 90 days post procedure. We will also be looking at financial data as well. * H(0): there is no economic benefit to the system with early surgical intervention for ICH * Alternative Hypothesis:H(1) Assuming clinical equipoise, i.e., no benefit in clinical outcome with early surgical intervention (null hypotheses) H(0) is correct), the ability to accelerate the patients care from the entry point to the exit point will result in a significant economic advantage to the system through cost reduction.
Key facts
- Study ID
- NCT01971359
- Run by
- OSF Healthcare System
- People needed
- 2
- Starts
- 2013-09-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2016-05-19
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inclusion Criteria:
- Consecutive patients aged at 18-80 presenting with an acute symptomatic supratertorial primary ICH diagnosed by CT
- Symptom onset to surgery <24 hours (target <8 hours)
- Glascow Coma Score > 9
- Hematoma Volume, between 10ml and 50ml.
- Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)
- NIHSS of >4 or deterioration determined by a neurologist.
You may not qualify if…
- Suspected secondary ICH
- Infratentorial ICH
- Isolated IVH
- Uncorrected coagulopathy
- Significant premorbid disability (mRS >1)
- Hydrocephalus
- Contraindication to safe surgical procedure as per neurosurgeon (justification for exclusion on this basis will be recorded)
Where it is running
- OSF St. Francis Medical Center — Peoria, Illinois, United States
Full record on ClinicalTrials.gov
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