Injured Spinal Cord Pressure Evaluation

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Procedure: Insertion of intra spinal sub dural pressure monitor
* Procedure: Insertion of sub dural microdialysis probe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laminectomy<br>Comparison of bone decompression versus no decompression for reducing intra spinal pressure | Procedure: Insertion of intra spinal sub dural pressure monitor<br> <br> * Other names: codman microsensor transducer. Ref. 626638;|
| Active Comparator: Duraplasty<br>Expansion duraplasty versus no duraplasty for reducing intraspinal pressure | Procedure: Insertion of intra spinal sub dural pressure monitor<br> <br> * Other names: codman microsensor transducer. Ref. 626638;Procedure: Insertion of sub dural microdialysis probe<br> <br> * Other names: CMA61, CMA microdialysis AB. Ref.8010226;|
| Active Comparator: Hypothermia<br>Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism | Procedure: Insertion of intra spinal sub dural pressure monitor<br> <br> * Other names: codman microsensor transducer. Ref. 626638;Procedure: Insertion of sub dural microdialysis probe<br> <br> * Other names: CMA61, CMA microdialysis AB. Ref.8010226;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra spinal pressure | Intra spinal pressure measured for up to 7 days using sub dural probe | 0-7 days | 
| Spinal metabolites | Spinal cord metabolites measured using microdialysis probe | 0-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra spinal pressure, spinal cord perfusion pressure, microdialysis, duroplasty