Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study (CASPER)
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|ClinicalTrials.gov Identifier: NCT03911492|
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : September 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Spinal Cord Injury Acute Spinal Paralysis Spinal Cord Injuries SPINAL Fracture||Procedure: SCPP Management => 65 mmHg||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study|
|Actual Study Start Date :||August 31, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
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.
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911492
|Contact: Allison Colemanfirstname.lastname@example.org|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Allan Aludino, Research Program Manager 1-604-875-4111 ext 61689 Allan.Aludino@vch.ca|
|Principal Investigator: Brian Kwon, MD, PhD|
|Principal Investigator:||Brian Kwon, MD, PhD||University of British Columbia, Faculty of Medicine|