Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study (MISPACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01971359
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : May 19, 2016
Information provided by (Responsible Party):
Andrew Tsung, OSF Healthcare System

Brief Summary:

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.

Condition or disease
Intracerebral Hemorrhage

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources


Primary Outcome Measures :
  1. 30-90 day outcomes [ Time Frame: 30-90 days ]
    The primary objective is to compare the 30 day and 90 day clinical outcomes of patients who will undergo parafascicular ICH-evacuation procedure compared to historical outcomes (surgical and non-surgical).

Secondary Outcome Measures :
  1. Surgery success rates [ Time Frame: 30-90 days ]
    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.

Other Outcome Measures:
  1. Financial outcomes [ Time Frame: 30-90 days ]
    We also will be looking at the financial aspect of current medical management and minimally invasive surgeries compared to the parafascicular technique.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients that present with an ICH at OSF St. Francis Medical Center

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01971359

United States, Illinois
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Sponsors and Collaborators
OSF Healthcare System
Principal Investigator: Andrew Tsung, M.D. OSF St. Francis Medical Center

Responsible Party: Andrew Tsung, Andrew Tsung M.D., OSF Healthcare System Identifier: NCT01971359     History of Changes
Other Study ID Numbers: OSF-13-004
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016

Keywords provided by Andrew Tsung, OSF Healthcare System:
Stroke, Intracerebral Hemorrhage, ICH

Additional relevant MeSH terms:
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases