Acute Spinal Cord InjuryCASPERNCT03911492
Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
A study testing SCPP Management => 65 mmHg in people with Acute Spinal Cord Injury and Acute Spinal Paralysis, run by University of British Columbia at 8 sites in 2 countries.
Trial 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)… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Acute Spinal Cord Injury, Acute Spinal Paralysis, Spinal Cord Injuries
- What is being tested?
- SCPP Management => 65 mmHg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 31 Aug 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Amal Alchbli
Christian Ricks, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Dulce Maroni
Jamie Wilson, MD
- Recruiting
University Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
David Okonkwo
- Recruiting
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
Xuan Duong Fernandez
Anthony DiGiorgio, MD
Canada4 sites, 4 recruiting
- Recruiting
Halifax Infirmary - QEII
Halifax, Nova Scotia, B3K 4N1
Sean Christie, MD
- Recruiting
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5
Pascal Mputu
Jean-Marc Mac-Thiong, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Cecilia He
Jeff Wilson, MD
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Allan Aludino, Research Program Manager, 1-604-875-4111 ext. 61689, Allan.Aludino@vch.ca
Brian Kwon, MD, PhD
About this study
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.
Read the 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.
- Being tested
- SCPP Management => 65 mmHg
- Keywords
- SCI, Spinal Cord Injury, CSF, Biomarker, CSF pressure, Traumatic SCI, Perfusion pressure
- Medical subject headings
- Spinal Cord Injuries, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCPP Management => 65 mmHgProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SCP Pressure Management | Other | Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg. Receives: Procedure: SCPP Management => 65 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 7 days
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start31 Aug 2019
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Rick Hansen Institute
- Responsible party
- Principal investigator, Brian Kwon, University of British Columbia
- Investigators
- Brian Kwon, MD, PhD, Principal investigator, University of British Columbia, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911492
- Sponsor's protocol ID
- H19-00805
- Acronym
- CASPER
- Status last verified
- Jun 2023
- First submitted
- 9 Apr 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study
- ClinicalTrials.gov ID
- NCT03911492
- Acronym / sponsor ID
- CASPER / H19-00805
- Keywords
- SCI, Spinal Cord Injury, CSF, Biomarker, CSF pressure, Traumatic SCI, Perfusion pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Rick Hansen Institute
- Study start
- 31 Aug 2019 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCP Pressure Management | Other | Procedure: SCPP Management => 65 mmHgActive management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCPP Management => 65 mmHgA 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. | Procedure or surgery | SCP Pressure Management |
Primary outcome
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).
2 secondary outcomes
Levels of specific biochemical markers in CSF and Blood
Time frame: 7 days
Spinal Cord Perfusion Pressure (SCPP)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Kwon, MD, PhD principal investigator
University of British Columbia, Faculty of Medicine
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCPP Management => 65 mmHg in people with Acute Spinal Cord Injury and Acute Spinal Paralysis, run by University of British Columbia at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan Aludino (604-875-4111 ext. 61689, allan.aludino@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.