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Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study (CASPER)

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ClinicalTrials.gov Identifier: NCT03911492
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Rick Hansen Institute
Information provided by (Responsible Party):
Brian Kwon, University of British Columbia

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 11, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE August 31, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination [ Time Frame: 12 months ]
Neurologic recovery over time will be measured using the ISNCSCI examination - at Baseline, Days 1-7, and months 3, 6 and 12. Our primary outcome measure will be the change in total motor score at 6 months post-injury (a time point at which most motor recovery has occurred and is commonly used in acute SCI clinical trials).
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
ISNCSCI Examination [ Time Frame: 6 months ]
Neurologic recovery will be measured using the ISNCSCI examination. Our primary outcome measure will be the change in total motor score at 6 months post-injury (a time point at which most motor recovery has occurred and is commonly used in acute SCI clinical trials).
Change History Complete list of historical versions of study NCT03911492 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Levels of specific biochemical markers in CSF and Blood [ Time Frame: 7 days ]
    CSF and blood samples will be obtained from the intrathecal catheter at 8-hour intervals, three times daily, for 7 days. These samples will be markers that correlate with injury severity and predict neurological outcome.
  • Spinal Cord Perfusion Pressure (SCPP) [ Time Frame: 7 days ]
    SCPP will be calculated as the difference between the mean arterial pressure and intrathecal pressure. The MAP and ITP will recorded over 7 days post injury.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
Official Title  ICMJE Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
Brief Summary

This multicenter study will enroll 100 patients with acute traumatic cervical and thoracic SCI who have a lumbar intrathecal catheter inserted within 24 hours of their injury. The lumbar intrathecal catheter will be inserted pre-operatively for the measurement of ITP and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between MAP and the ITP.

There are two important distinct yet related objectives in this prospective interventional study.

  1. Determine the effect of SCPP maintenance ≥ 65 mmHg in acute SCI on neurologic recovery as measured by ASIA Impairment Scale (AIS) grade conversion and motor score improvement.
  2. Collect CSF and blood samples for the measurement of neurochemical biomarkers and storage for future biomarker discovery and validation studies.
Detailed Description

Objective 1. To determine if actively maintaining an SCPP of at least 65 mmHg with a combination of MAP augmentation and CSF drainage promotes better neurologic recovery than routine hemodynamic management that focuses solely on MAP augmentation.

Objective 2. To determine if actively maintaining an SCPP of at least 65 mmHg with a combination of MAP augmentation and CSF drainage will allow for a reduction in the usage of vasopressors in acute SCI.

Objective 3. To determine the feasibility of draining CSF to reduce ITP in the acute post-injury setting, when the cord may be swollen against the dura causing subarachnoid space occlusion at the injury site.

Objective 4. To determine if there are complications associated with the installation of the intrathecal catheter and drainage of CSF in the acute SCI patient.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Spinal Cord Injury
  • Acute Spinal Paralysis
  • Spinal Cord Injuries
  • SPINAL Fracture
Intervention  ICMJE Procedure: SCPP Management => 65 mmHg
A lumbar intrathecal catheter will be inserted pre-operatively for the measurement of Intrathecal pressure (ITP) and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between Mean Arterial Pressure (MAP) and the ITP.
Study Arms  ICMJE SCP Pressure Management
Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.
Intervention: Procedure: SCPP Management => 65 mmHg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female ≥ 17 (or the provincial age of majority - depending on local REB guidelines)
  • Complete (AIS A) or incomplete (AIS B, C) acute traumatic spinal cord injury.
  • Bony spinal levels between C0 and T12 inclusive.
  • Blunt (non-penetrating) spinal cord injury treated either surgically or non-surgically
  • Lumbar intrathecal catheter to be inserted as part of clinical hemodynamic management within 24 hours of injury

Exclusion Criteria:

  • Motor incomplete spinal cord injury AIS D (i.e. at least half (half or more) of the key muscle functions below the neurological level of injury (NLI) have a muscle grade greater than or equal to 3/5)
  • Spinal cord injury with sensory deficit only (i.e. no motor deficit)
  • Penetrating spinal cord injury (including gunshot wounds)
  • Isolated radiculopathy
  • Isolated cauda equina injury or spinal injury below L1
  • Associated injury (soft tissue or bony) to the lumbar spine where the intrathecal catheter would be placed
  • Associated traumatic conditions that would interfere with the outcome assessment (e.g., traumatic brain injury, chest, pelvis, abdomen, or femur injury requiring operative intervention)
  • Pre-existing neurodegenerative disorder, such as Parkinson's disease, Alzheimer's disease, Huntington's disease, multiple sclerosis, amyotrophic lateral sclerosis
  • Pre-existing thromboembolic disease or coagulopathy, such as hemophilia, von Willebrand disease
  • Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g., clinically significant cardiac disease, HIV, Hep B or C) HTLV-1
  • Pre-existing inflammatory or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus, psoriasis, or ankylosing spondylitis
  • Any other medical condition that in the investigator's opinion would render the protocol procedures dangerous or impair the ability of the patient to receive protocol therapy
  • Female patients who are pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Allison Coleman 1-604-827-1852 acoleman@rickhanseninstitute.org
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03911492
Other Study ID Numbers  ICMJE H19-00805
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Kwon, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Rick Hansen Institute
Investigators  ICMJE
Principal Investigator: Brian Kwon, MD, PhD University of British Columbia, Faculty of Medicine
PRS Account University of British Columbia
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP