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

Primary Purpose

Acute Spinal Cord Injury, Acute Spinal Paralysis, Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SCPP Management => 65 mmHg
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Spinal Cord Injury focused on measuring SCI, Spinal Cord Injury, CSF, Biomarker, CSF pressure, Traumatic SCI, Perfusion pressure

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zuckerberg San Francisco General Hospital and Trauma CenterRecruiting
  • University of Nebraska Medical CenterRecruiting
  • University of New Mexico Health Sciences CenterRecruiting
  • University Pittsburgh Medical CenterRecruiting
  • Vancouver General HospitalRecruiting
  • Halifax Infirmary - QEIIRecruiting
  • St. Michael's HospitalRecruiting
  • Hopital Du Sacre-Coeur de MontrealRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SCP Pressure Management

Arm Description

Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.

Outcomes

Primary Outcome Measures

International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
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

Levels of specific biochemical markers in CSF and Blood
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)
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.

Full Information

First Posted
April 9, 2019
Last Updated
June 30, 2023
Sponsor
University of British Columbia
Collaborators
Rick Hansen Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03911492
Brief Title
Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
Acronym
CASPER
Official Title
Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2019 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Rick Hansen Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCP Pressure Management
Arm Type
Other
Arm Description
Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.
Intervention Type
Procedure
Intervention Name(s)
SCPP Management => 65 mmHg
Intervention Description
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 Measure Information:
Title
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Levels of specific biochemical markers in CSF and Blood
Description
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.
Time Frame
7 days
Title
Spinal Cord Perfusion Pressure (SCPP)
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Aludino
Phone
604-875-4111
Ext
61689
Email
allan.aludino@vch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Kwon, MD, PhD
Organizational Affiliation
University of British Columbia, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital and Trauma Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuan Duong Fernandez
First Name & Middle Initial & Last Name & Degree
Anthony DiGiorgio, MD
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dulce Maroni
First Name & Middle Initial & Last Name & Degree
Jamie Wilson, MD
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal Alchbli
First Name & Middle Initial & Last Name & Degree
Christian Ricks, MD
Facility Name
University Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Okonkwo
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan Aludino, Research Program Manager
Phone
1-604-875-4111
Ext
61689
Email
Allan.Aludino@vch.ca
First Name & Middle Initial & Last Name & Degree
Brian Kwon, MD, PhD
Facility Name
Halifax Infirmary - QEII
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 4N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Christie, MD
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia He
First Name & Middle Initial & Last Name & Degree
Jeff Wilson, MD
Facility Name
Hopital Du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Mputu
First Name & Middle Initial & Last Name & Degree
Jean-Marc Mac-Thiong, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

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