Injured Spinal Cord Pressure Evaluation

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Procedure: Insertion of intra spinal sub dural pressure monitor; Procedure: Insertion of sub dural microdialysis probe

• Registration Number: NCT02721615
• Lead Sponsor: St George's, University of London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-03
• Primary Completion: 2024-09
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypothermia	Insertion of intra spinal sub dural pressure monitor	Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism
Hypothermia	Insertion of sub dural microdialysis probe	Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism
Laminectomy	Insertion of intra spinal sub dural pressure monitor	Comparison of bone decompression versus no decompression for reducing intra spinal pressure
Duraplasty	Insertion of intra spinal sub dural pressure monitor	Expansion duraplasty versus no duraplasty for reducing intraspinal pressure
Duraplasty	Insertion of sub dural microdialysis probe	Expansion duraplasty versus no duraplasty for reducing intraspinal pressure

Primary Outcome Measures

Name	Time	Method
Intra spinal pressure	0-7 days	Intra spinal pressure measured for up to 7 days using sub dural probe
Spinal metabolites	0-7 days	Spinal cord metabolites measured using microdialysis probe

Trial Locations

Locations (1)

St George's, University of London; 🇬🇧 London, United Kingdom