Evaluation of Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation
Condition: Cerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Observational [Patient Registry]

Summary: 
      Intracerebral hemorrhage (ICH) is the most severe form of stroke: early mortality is 40%, and
      80%-of survivors are physically disabled with high rates of cognitive impairment and
      depression.

      In an effort to address the issues with conventional treatments, a new integrated systematic
      approach has been developed. This approach utilizes an educational process where specific
      core competencies (pillars) of mapping, navigation, access, optics and automated resection
      have been integrated into a single standardized system to deliver targeted therapy for an
      individual patient based on location and patient factors. This system has demonstrated safety
      and efficacy in oncology patients and is also FDA approved for use in the ICH patient
      population as well.

      This registry will collect data form multiple site that preform the MiSPACE procedure as part
      of clinical care. The intent of this registry is to collect data on the economic impact as
      well as clinical outcomes using the MiSPACE approach with the integrated technology in the
      early treatment of ICH.
    

Detailed description: 
      Aurora Health Care is serving as the coordinating center and will prepare Standard Operating
      Procedures to address registry operations and analysis activities, such as patient
      recruitment, data collection, data management, data analysis, and reporting for adverse
      events.

      Sites will identify, recruit, obtain consent for subjects and collect data using standard
      forms; these activities will be monitored remotely by the coordinating site. Data from the
      participating hospitals will be checked for heterogeneity, queried and subsequently pooled.
      Baseline patient characteristics and demographics, Hemphill and Essen predictive scores,
      NIHSS stroke severity score, functional status from the Barthel index and mRS score, and ICH
      volumetric assessments, will be presented as means, medians, or proportions, as appropriate.
      Eligibility and consent rates will be derived for each center.

      Analyses will be largely descriptive in nature. Follow-up assessments at 30 and 90 days, for
      composite outcome of death or disability (defined as mRS>2), and death and disability
      separately, will be described with proportions. Tallies of surgical complications will also
      be derived as separate outcomes.

      Analysis of 30- and 90-day status will entail an informal comparison for the purposes of
      providing preliminary evidence and for planning of a larger comparative trial. The proportion
      of patients under experimental treatment who suffer from death or dependency at 30-days, as
      determined by cutoffs on the modified Rankin Scale with exact binomial upper and lower 90%
      confidence limits will be used in a comparison to our criteria of: (1) 65% (historical
      proportion of patients under medical management, unselected for baseline risk), and (2) 50%
      (proportion of patients under other minimally invasive surgical techniques unselected for
      baseline risk). This confidence limit comparative approach provides a flexible method of
      assessment of non-inferiority, equivalence, and superiority. The unselected population will,
      however, be a mix of patients at different levels of baseline risk, and so a follow-up
      stratified analysis will be conducted if counts permit. The unselected population will be
      matched using demographics, lesion characteristics and comorbidities as close as possible to
      the study group. A heterogeneity index will be used for comparison. As a corollary to this
      analysis, baseline predictive scores (translated from scores to percentages/risks) will be
      used to calculate expected counts of 30 and 90 day status stratified within the 0-3 range of
      the Hemphill ICH score and 0-10 range of the Essen ICH score, and these expected counts will
      be compared to observed counts using a Fisher Exact Test.

      Fifty (50) patients were chosen as a convenient sample size, based on enrollments from all of
      the participating hospitals, with recruitment accomplished in a reasonable timeframe of 2
      years. About 65% of unselected patients with ICH (that is, 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 minimallyinvasive ICH surgeries provide
      evidence of significantly improved outcomes (meta-analysis odds ratio 0.54 (0.39, 0.76)). An
      odds ratio of 0.54 indicates a reduction in risk from 65% to about 50% (15% absolute
      reduction).

      Assuming the new procedure is truly at least as effective as other minimally invasive
      surgeries (50% 30-day composite outcome risk), and therefore 15% more effective than
      conventional management, 50 patients provides 66% surity that a 95% 1-sided confidence
      interval will exclude the chance that the new procedure is worse than medical management.

      An alternative 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% surity/power that the new procedure is superior to medical management
      (i.e., lower than 65% suffering from death or poor functional outcomes). The computed
      critical value for this test, to provide some initial evidence of superiority, is observing
      no more than 26 patients (out of 50) suffering from death or dependency under the new
      surgical procedure. The surity/power of 66% used as an assumption above is permissive. The
      study size and preliminary nature of the results will not be sufficient to perform robust
      statistical testing for superiority or non-inferiority of the new parafascicular
      ICH-evacuation technique, though results from this registry will provide a crucial first look
      at effectiveness, and health costs.
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients treated for subcortical intracerebral hemorrhage (ICH) using a systems approach
        which integrates five separate core competencies for safe and consistent parafascicular
        minimally invasive subcortical (MIS) access
      
Keywords: intracerebral hemorrhage; subcortical intracerebral hemorrhage; ICH; parafascicular minimally invasive subcortical access