Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study (MISPACE)
Verified April 2014 by OSF Healthcare System
Information provided by (Responsible Party):
Andrew Tsung, OSF Healthcare System
First received: October 23, 2013
Last updated: April 25, 2014
Last verified: April 2014
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
Primary Outcome Measures:
Secondary Outcome Measures:
- Surgery success rates [ Time Frame: 30-90 days ] [ Designated as safety issue: No ]
Another objective will be to describe and quantify peri-operative complications following the parafascicular ICH evacuation. We will assess the success rates of; atraumatic access to the hematoma, effective removal of fibrotic clot by measuring residual hematoma, the ability to achieve hemostasis intra-operatively, and to compare postoperative re-bleeding rates against residual clot volume.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
Patients will be recruited form the neurology and neurosurgery services at OSF Saint Francis Medical Center. Potential subjects will be identified by the study team which will include all investigators and study coordinators. For those patients who have had the Mi Space procedure, the study team will obtain the patients or patient's surrogate consent for clinical data of hospitalization and follow ups. A secured, de-identified log will be kept of all patients screened, and reasons for exclusion will be documented. Around 65% of unselected patients with ICH (not stratified by baseline predicted risk) have a documented 30 day composite outcome of death or dependency under medical management. Reviews of other types of minimally-invasive ICH surgeries provides data that significantly improved outcomes (meta-analysis odds ratio 0.54(0.39, 0.76)). An odds ratio of 0.54 shows a reduction in risk from 65% to about 50% (15% absolute reduction). Assuming the new procedure is at least as effective than current conventional management, 50 patients provides 66% surety that a 95% 1-sided confidence interval will exclude the chance that the new procedure is worse than medical management. Alternatively, a method of framing this, based on an exact one-sided binomial test of a one-sample proportion and an alpha level of 5%, is that a sample size of 50 patients provides approximately 66% surety/power that the new procedure is superior to medical management (i.e., lower than 65% suffering from death or poor functional outcomes). The critical computed value for this particular test, to provide some initial evidence of superiority, are observing no more than 26 patients (out of 50) suffering from death or dependency under the surgical procedure.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients that present with an ICH at OSF St. Francis Medical Center
1. 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.
- Suspected secondary ICH
- Infratentorial ICH
- Isolated IVH
- Uncorrected coagulopathy
- Significant premorbid disability (mRS >1)
- Contraindication to safe surgical procedure as per neurosurgeon (justification for exclusion on this basis will be recorded)
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01971359
|OSF St. Francis Medical Center
|Peoria, Illinois, United States, 61637 |
|Principal Investigator: Andrew Tsung, M.D. |
OSF Healthcare System
||Andrew Tsung, M.D.
||OSF St. Francis Medical Center
No publications provided
||Andrew Tsung, Andrew Tsung M.D., OSF Healthcare System
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 23, 2013
||April 25, 2014
||United States: Institutional Review Board
Keywords provided by OSF Healthcare System:
Stroke, Intracerebral Hemorrhage, ICH
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 04, 2016
Central Nervous System Diseases
Nervous System Diseases