Injured Spinal Cord Pressure Evaluation (ISCoPE)

St George's, University of London

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Procedure: Insertion of sub dural microdialysis probe; Procedure: Insertion of intra spinal sub dural pressure monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02721615

10/H0807/23 (Registry Identifier)

09.0151

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Laminectomy

Active Comparator group

Description:

Comparison of bone decompression versus no decompression for reducing intra spinal pressure

Treatment:

Procedure: Insertion of intra spinal sub dural pressure monitor

Duraplasty

Active Comparator group

Description:

Expansion duraplasty versus no duraplasty for reducing intraspinal pressure

Treatment:

Procedure: Insertion of intra spinal sub dural pressure monitor

Procedure: Insertion of sub dural microdialysis probe

Hypothermia

Active Comparator group

Description:

Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism

Treatment:

Procedure: Insertion of intra spinal sub dural pressure monitor

Procedure: Insertion of sub dural microdialysis probe