Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
NCT ID: NCT03911492
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2019-08-31
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SCP Pressure Management
Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
No
Sponsors
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Rick Hansen Institute
OTHER
University of British Columbia
OTHER
Responsible Party
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Brian Kwon
Principal Investigator
Principal Investigators
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Brian Kwon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia, Faculty of Medicine
Locations
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Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vancouver General Hospital
Vancouver, British Columbia, Canada
Halifax Infirmary - QEII
Halifax, Nova Scotia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Xuan Duong Fernandez
Role: primary
Dulce Maroni
Role: primary
Amal Alchbli
Role: primary
Cecilia He
Role: primary
Pascal Mputu
Role: primary
Other Identifiers
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H19-00805
Identifier Type: -
Identifier Source: org_study_id
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