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Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study

NCT03911492 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-03

No results posted yet for this study

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.

Conditions

  • Acute Spinal Cord Injury
  • Acute Spinal Paralysis
  • Spinal Cord Injuries
  • SPINAL Fracture

Interventions

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.

Sponsors & Collaborators

  • Rick Hansen Institute

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Brian Kwon, MD, PhD · University of British Columbia, Faculty of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2025-03-31
Completion
2025-12-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911492 on ClinicalTrials.gov