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Injured Spinal Cord Pressure Evaluation (ISCoPE)

This study is currently recruiting participants.
Verified April 2017 by St George's, University of London
Sponsor:
ClinicalTrials.gov Identifier:
NCT02721615
First Posted: March 29, 2016
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St George's, University of London
March 17, 2016
March 29, 2016
April 26, 2017
September 2010
February 2019   (Final data collection date for primary outcome measure)
  • Intra spinal pressure [ Time Frame: 0-7 days ]
    Intra spinal pressure measured for up to 7 days using sub dural probe
  • Spinal metabolites [ Time Frame: 0-7 days ]
    Spinal cord metabolites measured using microdialysis probe
Same as current
Complete list of historical versions of study NCT02721615 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Injured Spinal Cord Pressure Evaluation
Evaluation of the Potential Adverse Effect of Pressure After Spinal Cord Injury

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Spinal Cord Injuries
  • Procedure: Insertion of intra spinal sub dural pressure monitor
    Other Name: codman microsensor transducer. Ref. 626638
  • Procedure: Insertion of sub dural microdialysis probe
    Other Name: CMA61, CMA microdialysis AB. Ref.8010226
  • Active Comparator: Laminectomy
    Comparison of bone decompression versus no decompression for reducing intra spinal pressure
    Intervention: Procedure: Insertion of intra spinal sub dural pressure monitor
  • Active Comparator: Duraplasty
    Expansion duraplasty versus no duraplasty for reducing intraspinal pressure
    Interventions:
    • Procedure: Insertion of intra spinal sub dural pressure monitor
    • Procedure: Insertion of sub dural microdialysis probe
  • Active Comparator: Hypothermia
    Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism
    Interventions:
    • Procedure: Insertion of intra spinal sub dural pressure monitor
    • Procedure: Insertion of sub dural microdialysis probe

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2019
February 2019   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact: Marios C Papadopoulos, MD 0208 7254179 mpapadop@sgul.ac.uk
Contact: Samira Saadoun, PhD 0208 7254179 ssaadoun@sgul.ac.uk
United Kingdom
 
 
NCT02721615
09.0151
10/H0807/23 ( Registry Identifier: Research ethics commitee - Camberwell St Giles )
No
Not Provided
Plan to Share IPD: No
St George's, University of London
St George's, University of London
Not Provided
Principal Investigator: Marios C Papadopoulos, MD St George's, University of London
St George's, University of London
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP