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
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|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||16 participants|
|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|
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.
This is a retrospective records review of patients who received either medical intervention or conventional surgical intervention for the treatment of their ICH.
- 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.
- 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).
- 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.
- 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.
- 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.
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
|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|
|Principal Investigator:||Amin B Kassam, MD||Aurora Health Care|