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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.
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.
Age
17 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 31, 2019
Primary Completion Date
March 1, 2025
Completion Date
December 1, 2025
Last Updated
July 3, 2023
100
ESTIMATED participants
SCPP Management => 65 mmHg
PROCEDURE
Lead Sponsor
University of British Columbia
Collaborators
NCT05563103
NCT06521723
NCT07386522
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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