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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

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.

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Acute Spinal Paralysis Spinal Cord Injuries SPINAL Fracture Procedure: SCPP Management => 65 mmHg Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
Actual Study Start Date : August 31, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
SCP Pressure Management
Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03911492


Contacts
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Contact: Allison Coleman 1-604-827-1852 acoleman@rickhanseninstitute.org

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Allan Aludino, Research Program Manager    1-604-875-4111 ext 61689    Allan.Aludino@vch.ca   
Principal Investigator: Brian Kwon, MD, PhD         
Sponsors and Collaborators
University of British Columbia
Rick Hansen Institute
Investigators
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Principal Investigator: Brian Kwon, MD, PhD University of British Columbia, Faculty of Medicine

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Responsible Party: Brian Kwon, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03911492     History of Changes
Other Study ID Numbers: H19-00805
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Kwon, University of British Columbia:
SCI
Spinal Cord Injury
CSF
Biomarker
CSF pressure
Traumatic SCI
Perfusion pressure
Additional relevant MeSH terms:
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Spinal Cord Injuries
Paralysis
Spinal Fractures
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Signs and Symptoms
Spinal Injuries
Back Injuries
Fractures, Bone