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

June 30, 2023 updated by: Brian Kwon, University of British Columbia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
          • Allan Aludino, Research Program Manager
          • Phone Number: 61689 1-604-875-4111
          • Email: Allan.Aludino@vch.ca
        • Principal Investigator:
          • Brian Kwon, MD, PhD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 4N1
        • Recruiting
        • Halifax Infirmary - QEII
        • Principal Investigator:
          • Sean Christie, MD
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Contact:
          • Cecilia He
        • Principal Investigator:
          • Jeff Wilson, MD
    • Quebec
      • Montreal, Quebec, Canada, H4J1C5
        • Recruiting
        • Hopital Du Sacre-Coeur de Montreal
        • Contact:
          • Pascal Mputu
        • Principal Investigator:
          • Jean-Marc Mac-Thiong, MD
  • United States
    • California
      • San Francisco, California, United States, 94110
        • Recruiting
        • Zuckerberg San Francisco General Hospital and Trauma Center
        • Contact:
          • Xuan Duong Fernandez
        • Principal Investigator:
          • Anthony DiGiorgio, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Dulce Maroni
        • Principal Investigator:
          • Jamie Wilson, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico Health Sciences Center
        • Contact:
          • Amal Alchbli
        • Principal Investigator:
          • Christian Ricks, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University Pittsburgh Medical Center
        • Principal Investigator:
          • David Okonkwo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 and CSF sample collected within 48 hours of injury
  • Initial blood sample collected 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Rick Hansen Institute

Investigators

  • Principal Investigator: Brian Kwon, MD, PhD, University of British Columbia, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2019

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H19-00805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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