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Trial record 1 of 1 for:    NCT02331719
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Evaluation of Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation (MiSPACE)

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ClinicalTrials.gov Identifier: NCT02331719
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Amin B Kassam, Aurora Health Care

Brief 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.


Condition or disease
Cerebral Hemorrhage

Show Show detailed description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 16 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 90 Days
Official Title: Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation
Study Start Date : August 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort
MiSPACE Eligible Cohort
This will be a prospective record review of patients where the MiSPACE technique is being/was used for the treatment of their ICH.
Historical Cohort
This is a retrospective records review of patients who received either medical intervention or conventional surgical intervention for the treatment of their ICH.



Primary Outcome Measures :
  1. Overall surgical performance. [ Time Frame: 30 days after procedure ]
    Overall surgical performance is a composite outcome measure that will be assessed by evaluating a number of events and outcomes. Data will be collected on any surgical complications (defined as peri-operative blood loss, thrombotic events, infections, neurological worsening, seizures, metabolic disturbances, and cardiopulmonary events, within 30 days of surgery). Data from re-admissions within the first 30 days will also be included. In addition, data regarding the duration of surgery, time to reach the hematoma, intra-operative monitoring, blood transfusion, use of hemostatic agents, use of post-operative ICP monitoring, residual post-operative hematoma volumes, and post-operative recurrence of hematoma will also be collected.


Secondary Outcome Measures :
  1. Peri-operative complications following parafascicular ICH evacuation. [ Time Frame: 90 days after procedure ]

    Peri-operative complications following parafascicular ICH evacuation will be described and quantified.

    Data will be collected on any surgical complications (defined as peri-operative blood loss, thrombotic events, infections, neurological worsening, seizures, metabolic disturbances, and cardiopulmonary events, within 30/90 days of surgery).


  2. 30-day clinical outcomes of patients who had parafascicular ICH-evacuation surgery [ Time Frame: 30 days after procedure ]
    A mRS-certified investigator/delegate will perform a clinical assessment at 30-days and 90-days. In cases where a subject is discharged and unable to attend a follow-up appointment, a standardized telephone mRS interview will be conducted.

  3. 90-day clinical outcomes of patients who had parafascicular ICH-evacuation surgery [ Time Frame: 90 days after procedure ]
    A mRS-certified investigator/delegate will perform a clinical assessment at 30-days and 90-days. In cases where a subject is discharged and unable to attend a follow-up appointment, a standardized telephone mRS interview will be conducted.

  4. Inpatient care costs of patients undergoing Parafascicular ICH surgery and patients managed with medical treatment alone or those with conventional surgical treatment. [ Time Frame: 90 days after procedure ]

    An economic analysis comparing inpatient care costs of patients undergoing Parafascicular ICH surgery to patients managed with medical treatment alone or those with conventional surgical treatment. will be completed.

    We will present all the financial results in a relative form using the costreimbursement ratio (CRR); the CRR is simply the ratio of the total cost per patient to the total reimbursement per patient.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Presented with acute symptomatic supratentorial primary ICH diagnosed by CT
  • Has made the clinical treatment decision to have parafascicular minimally invasive subcortical (MIS) access to treat subcortical intracerebral hemorrhage (ICH) using the systems approach outlined in this protocol
  • 18 - 80 years old
  • Symptom onset to surgery < 24 hours (target < 8hours)
  • Presurgical Glascow Coma Score ≥ 8
  • Hematoma volume < 60ml
  • Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)

Exclusion Criteria:

  • Suspected secondary ICH
  • Infratentorial ICH
  • Isolated IVH
  • Uncorrected coagulopathy
  • Significant premorbid disability (mRS>1)
  • Hydrocephalus
  • Contraindication to safe surgical procedure

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 ClinicalTrials.gov identifier (NCT number): NCT02331719


Locations
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United States, Arkansas
University Of Arkansas of Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University at Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
United States, Illinois
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Indiana
IU Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
United States, Missouri
St. Louis University
Saint Louis, Missouri, United States, 63110
United States, Ohio
Riverside Methodist Hospital (OhioHealth)
Columbus, Ohio, United States, 43214
United States, Wisconsin
Aurora Health Care, Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Amin B Kassam
Investigators
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Principal Investigator: Amin B Kassam, MD Aurora Health Care

Additional Information:

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Responsible Party: Amin B Kassam, Physician-Surgery Neuro, Aurora Health Care
ClinicalTrials.gov Identifier: NCT02331719    
Other Study ID Numbers: 14-39E
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amin B Kassam, Aurora Health Care:
intracerebral hemorrhage
subcortical intracerebral hemorrhage
ICH
parafascicular minimally invasive subcortical access
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases