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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by OSF Healthcare System
Sponsor:
Information provided by (Responsible Party):
Andrew Tsung, OSF Healthcare System
ClinicalTrials.gov Identifier:
NCT01971359
First received: October 23, 2013
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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
Intracerebral Hemorrhage

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Outcomes Following Parafascicular Surgical Evacuation of Intracerebral Hemorrhage: A Pilot Study

Resource links provided by NLM:


Further study details as provided by OSF Healthcare System:

Primary Outcome Measures:
  • 30-90 day outcomes [ Time Frame: 30-90 days ] [ Designated as safety issue: No ]
    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:
  • 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.


Other Outcome Measures:
  • Financial outcomes [ Time Frame: 30-90 days ] [ Designated as safety issue: No ]
    We also will be looking at the financial aspect of current medical management and minimally invasive surgeries compared to the parafascicular technique.


Estimated Enrollment: 10
Study Start Date: September 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Retrospective

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients that present with an ICH at OSF St. Francis Medical Center

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Contacts
Contact: April A Howarter, BSN 309-624-2409 April.a.Howarter@osfhealthcare.org

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

No publications provided

Responsible Party: Andrew Tsung, Andrew Tsung M.D., OSF Healthcare System
ClinicalTrials.gov Identifier: NCT01971359     History of Changes
Other Study ID Numbers: OSF-13-004
Study First Received: October 23, 2013
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 24, 2014