Clinical trial NCT03911492: Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
Official title: Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Spinal Cord Injury
Acute Spinal Paralysis
Spinal Cord Injuries
SPINAL Fracture
Keywords: SCI
Spinal Cord Injury
CSF
Biomarker
CSF pressure
Traumatic SCI
Perfusion pressure
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Rick Hansen Institute
First posted: 2019-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
timeFrame: 12 months
Secondary outcomes:
measure: Levels of specific biochemical markers in CSF and Blood
timeFrame: 7 days
measure: Spinal Cord Perfusion Pressure (SCPP)
timeFrame: 7 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital and Trauma Center
state: California
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Pittsburgh
country: United States
facility: University Pittsburgh Medical Center
state: Pennsylvania
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Halifax Infirmary - QEII
state: Nova Scotia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Du Sacre-Coeur de Montreal
state: Quebec
Study officials:
affiliation: University of British Columbia, Faculty of Medicine
name: Brian Kwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: