Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Observational

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.
    

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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients that present with an ICH at OSF St. Francis Medical Center
      
Keywords: Stroke, Intracerebral Hemorrhage, ICH