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Injured Spinal Cord Pressure Evaluation

NCT02721615 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-12-03

No results posted yet for this study

Summary

About a thousand people a year in the United Kingdom survive a spinal cord injury but are left paralysed or wheelchair-bound. The annual cost of care for spinal cord injury victims is more than half a billion pounds. We propose that after spinal cord injury, cord pressure at the injury site rises, damaging the spinal cord further by secondary ischaemia. The value of measuring and reducing cord pressure after spinal cord injury is unknown.

The injured spinal cord is compressed by bone malalignment and cord swelling. Current management involves realigning and fixing the bony fragments using metal screws, rods and plates. We hypothesise that: 1. Bony realignment alone does not adequately decompress the swollen cord, which remains compressed against the surrounding dura. 2. That duraplasty reduces intra spinal pressure more effectively than bone realignment alone. 3. Localised hypothermia reduces intra spinal pressure and improves metabolism.

We will develop a novel method to measure cord pressure and metabolism at the injury site after spinal cord injury and determine whether the cord pressure rises, for how long, and with what impact on spinal cord metabolism.

This is a pilot study to find out whether spinal cord pressure and metabolism can be measured after spinal cord injury and whether they are effected by treatment choices. We will examine if spinal cord perfusion pressure correlates with clinical outcomes.

Conditions

  • Spinal Cord Injuries

Interventions

PROCEDURE

Insertion of intra spinal sub dural pressure monitor

PROCEDURE

Insertion of sub dural microdialysis probe

Sponsors & Collaborators

  • Foundation Wings For Life

    collaborator OTHER

  • Neurosciences Research Foundation

    collaborator UNKNOWN

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Marios C Papadopoulos, MD · St George's, University of London

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2024-09-30
Completion
2025-04-30

Countries

  • United Kingdom

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 NCT02721615 on ClinicalTrials.gov