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Injured Spinal Cord Pressure Evaluation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02721615
Acronym
ISCoPE
Enrollment
100
Registered
2016-03-29
Start date
2010-09-30
Completion date
2025-04-30
Last updated
2020-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

intra spinal pressure, spinal cord perfusion pressure, microdialysis, duroplasty

Brief 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.

Interventions

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

Sponsors

Foundation Wings For Life
CollaboratorOTHER
Neurosciences Research Foundation
CollaboratorUNKNOWN
St George's, University of London
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Diagnosis of traumatic spinal cord injury American Spinal Injuries Association grade A-C spinal cord injury Presents within 72hrs of injury Capacity to consent for study

Exclusion criteria

Concurrent major co-morbidity likely to influence outcome Other major concurrent injury likely to influence outcome

Design outcomes

Primary

MeasureTime frameDescription
Intra spinal pressure0-7 daysIntra spinal pressure measured for up to 7 days using sub dural probe
Spinal metabolites0-7 daysSpinal cord metabolites measured using microdialysis probe

Countries

United Kingdom

Contacts

Primary ContactMarios C Papadopoulos, MD
mpapadop@sgul.ac.uk0208 7254179
Backup ContactSamira Saadoun, PhD
ssaadoun@sgul.ac.uk0208 7254179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026