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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
  Purpose

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.


Condition Intervention
Spinal Cord Injuries Procedure: Insertion of intra spinal sub dural pressure monitor Procedure: Insertion of sub dural microdialysis probe

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of the Potential Adverse Effect of Pressure After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by St George's, University of London:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laminectomy
Comparison of bone decompression versus no decompression for reducing intra spinal pressure
Procedure: Insertion of intra spinal sub dural pressure monitor
Other Name: codman microsensor transducer. Ref. 626638
Active Comparator: Duraplasty
Expansion duraplasty versus no duraplasty for reducing intraspinal pressure
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: Hypothermia
Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721615


Contacts
Contact: Marios C Papadopoulos, MD 0208 7254179 mpapadop@sgul.ac.uk
Contact: Samira Saadoun, PhD 0208 7254179 ssaadoun@sgul.ac.uk

Locations
United Kingdom
St George's, University of London Recruiting
London, United Kingdom, SW17 0RE
Contact: Marios C Papadopoulos, MD    0208 7254179    mpapadop@sgul.ac.uk   
Contact: Samira Saadoun, PhD    0208 7254179    ssaadoun@sgul.ac.uk   
Sponsors and Collaborators
St George's, University of London
Investigators
Principal Investigator: Marios C Papadopoulos, MD St George's, University of London
  More Information

Publications:

Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT02721615     History of Changes
Other Study ID Numbers: 09.0151
10/H0807/23 ( Registry Identifier: Research ethics commitee - Camberwell St Giles )
First Submitted: March 17, 2016
First Posted: March 29, 2016
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St George's, University of London:
intra spinal pressure
spinal cord perfusion pressure
microdialysis
duroplasty

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries