Evaluation of Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation

NCT02331719 | Completed

• 1 other identifier: 14-39E
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 8

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.

Conditions

Cerebral Hemorrhage

Keywords

intracerebral hemorrhage; subcortical intracerebral hemorrhage; ICH; parafascicular minimally invasive subcortical access

Outcome Measures

Primary Outcomes (1)

• Overall surgical performance.

  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.

  30 days after procedure

Secondary Outcomes (4)

• Peri-operative complications following parafascicular ICH evacuation.

  90 days after procedure

• 30-day clinical outcomes of patients who had parafascicular ICH-evacuation surgery

  30 days after procedure

• 90-day clinical outcomes of patients who had parafascicular ICH-evacuation surgery

  90 days after procedure

• Inpatient care costs of patients undergoing Parafascicular ICH surgery and patients managed with medical treatment alone or those with conventional surgical treatment.

  90 days after procedure

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (8)

University Of Arkansas of Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Emory University at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

IU Health Neuroscience Center

Indianapolis, Indiana, 46202, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Riverside Methodist Hospital (OhioHealth)

Columbus, Ohio, 43214, United States

Location

Aurora Health Care, Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amin B Kassam, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: January 6, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 3, 2024

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)