Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Zuckerberg San Francisco General Hospital and Trauma Center
RECRUITING
San Francisco
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New Mexico
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
Pennsylvania
University Pittsburgh Medical Center
RECRUITING
Pittsburgh
Other Locations
Canada
Halifax Infirmary - QEII
RECRUITING
Halifax
Hopital Du Sacre-Coeur de Montreal
RECRUITING
Montreal
St. Michael's Hospital
RECRUITING
Toronto
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
Allan Aludino
allan.aludino@vch.ca
604-875-4111
Time Frame
Start Date: 2019-08-31
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Other: SCP Pressure Management
Active management of Spinal Cord Perfusion Pressure (SCPP) at or above 65 mmHg.
Related Therapeutic Areas
Sponsors
Collaborators: Rick Hansen Institute
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov