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UnknownNCT02721615

Injured Spinal Cord Pressure Evaluation

Evaluation of the Potential Adverse Effect of Pressure After Spinal Cord Injury

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
St George's, University of London · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREInsertion of intra spinal sub dural pressure monitor
PROCEDUREInsertion of sub dural microdialysis probe

Timeline

Start date
2010-09-01
Primary completion
2024-09-01
Completion
2025-04-01
First posted
2016-03-29
Last updated
2020-12-03

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02721615. Inclusion in this directory is not an endorsement.