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Injured Spinal Cord Pressure Evaluation (ISCoPE)

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Insertion of intra spinal sub dural pressure monitor
Insertion of sub dural microdialysis probe
Sponsored by
St George's, University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Spinal Cord Injuries focused on measuring intra spinal pressure, spinal cord perfusion pressure, microdialysis, duroplasty

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St George's, University of LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Laminectomy

Duraplasty

Hypothermia

Arm Description

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

Expansion duraplasty versus no duraplasty for reducing intraspinal pressure

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

Outcomes

Primary Outcome Measures

Intra spinal pressure
Intra spinal pressure measured for up to 7 days using sub dural probe
Spinal metabolites
Spinal cord metabolites measured using microdialysis probe

Secondary Outcome Measures

Full Information

First Posted
March 17, 2016
Last Updated
December 1, 2020
Sponsor
St George's, University of London
Collaborators
Foundation Wings For Life, Neurosciences Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02721615
Brief Title
Injured Spinal Cord Pressure Evaluation
Acronym
ISCoPE
Official Title
Evaluation of the Potential Adverse Effect of Pressure After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St George's, University of London
Collaborators
Foundation Wings For Life, Neurosciences Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
intra spinal pressure, spinal cord perfusion pressure, microdialysis, duroplasty

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laminectomy
Arm Type
Active Comparator
Arm Description
Comparison of bone decompression versus no decompression for reducing intra spinal pressure
Arm Title
Duraplasty
Arm Type
Active Comparator
Arm Description
Expansion duraplasty versus no duraplasty for reducing intraspinal pressure
Arm Title
Hypothermia
Arm Type
Active Comparator
Arm Description
Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism
Intervention Type
Procedure
Intervention Name(s)
Insertion of intra spinal sub dural pressure monitor
Other Intervention Name(s)
codman microsensor transducer. Ref. 626638
Intervention Type
Procedure
Intervention Name(s)
Insertion of sub dural microdialysis probe
Other Intervention Name(s)
CMA61, CMA microdialysis AB. Ref.8010226
Primary Outcome Measure Information:
Title
Intra spinal pressure
Description
Intra spinal pressure measured for up to 7 days using sub dural probe
Time Frame
0-7 days
Title
Spinal metabolites
Description
Spinal cord metabolites measured using microdialysis probe
Time Frame
0-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marios C Papadopoulos, MD
Phone
0208 7254179
Email
mpapadop@sgul.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Samira Saadoun, PhD
Phone
0208 7254179
Email
ssaadoun@sgul.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marios C Papadopoulos, MD
Organizational Affiliation
St George's, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St George's, University of London
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marios C Papadopoulos, MD
Phone
0208 7254179
Email
mpapadop@sgul.ac.uk
First Name & Middle Initial & Last Name & Degree
Samira Saadoun, PhD
Phone
0208 7254179
Email
ssaadoun@sgul.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21939394
Citation
Werndle MC, Zoumprouli A, Sedgwick P, Papadopoulos MC. Variability in the treatment of acute spinal cord injury in the United Kingdom: results of a national survey. J Neurotrauma. 2012 Mar 20;29(5):880-8. doi: 10.1089/neu.2011.2038. Epub 2011 Oct 26.
Results Reference
background
PubMed Identifier
26641852
Citation
Phang I, Mada M, Kolias AG, Newcombe VF, Trivedi RA, Carpenter A, Hawkes RC, Papadopoulos MC. Magnetic Resonance Imaging of the Codman Microsensor Transducer Used for Intraspinal Pressure Monitoring: Findings From the Injured Spinal Cord Pressure Evaluation Study. Spine (Phila Pa 1976). 2016 May;41(10):E605-10. doi: 10.1097/BRS.0000000000001334.
Results Reference
result
PubMed Identifier
26273764
Citation
Varsos GV, Werndle MC, Czosnyka ZH, Smielewski P, Kolias AG, Phang I, Saadoun S, Bell BA, Zoumprouli A, Papadopoulos MC, Czosnyka M. Intraspinal pressure and spinal cord perfusion pressure after spinal cord injury: an observational study. J Neurosurg Spine. 2015 Dec;23(6):763-71. doi: 10.3171/2015.3.SPINE14870. Epub 2015 Aug 14.
Results Reference
result
PubMed Identifier
26136148
Citation
Phang I, Papadopoulos MC. Intraspinal Pressure Monitoring in a Patient with Spinal Cord Injury Reveals Different Intradural Compartments: Injured Spinal Cord Pressure Evaluation (ISCoPE) Study. Neurocrit Care. 2015 Dec;23(3):414-8. doi: 10.1007/s12028-015-0153-6.
Results Reference
result
PubMed Identifier
25705999
Citation
Phang I, Werndle MC, Saadoun S, Varsos G, Czosnyka M, Zoumprouli A, Papadopoulos MC. Expansion duroplasty improves intraspinal pressure, spinal cord perfusion pressure, and vascular pressure reactivity index in patients with traumatic spinal cord injury: injured spinal cord pressure evaluation study. J Neurotrauma. 2015 Jun 15;32(12):865-74. doi: 10.1089/neu.2014.3668. Epub 2015 May 4.
Results Reference
result
PubMed Identifier
24231762
Citation
Werndle MC, Saadoun S, Phang I, Czosnyka M, Varsos GV, Czosnyka ZH, Smielewski P, Jamous A, Bell BA, Zoumprouli A, Papadopoulos MC. Monitoring of spinal cord perfusion pressure in acute spinal cord injury: initial findings of the injured spinal cord pressure evaluation study*. Crit Care Med. 2014 Mar;42(3):646-55. doi: 10.1097/CCM.0000000000000028.
Results Reference
result
PubMed Identifier
29629987
Citation
Gallagher MJ, Zoumprouli A, Phang I, Schwab JM, Kopp MA, Liebscher T, Papadopoulos MC, Saadoun S. Markedly Deranged Injury Site Metabolism and Impaired Functional Recovery in Acute Spinal Cord Injury Patients With Fever. Crit Care Med. 2018 Jul;46(7):1150-1157. doi: 10.1097/CCM.0000000000003134.
Results Reference
result
PubMed Identifier
28351230
Citation
Chen S, Smielewski P, Czosnyka M, Papadopoulos MC, Saadoun S. Continuous Monitoring and Visualization of Optimum Spinal Cord Perfusion Pressure in Patients with Acute Cord Injury. J Neurotrauma. 2017 Nov 1;34(21):2941-2949. doi: 10.1089/neu.2017.4982. Epub 2017 May 24.
Results Reference
result
PubMed Identifier
27864426
Citation
Saadoun S, Chen S, Papadopoulos MC. Intraspinal pressure and spinal cord perfusion pressure predict neurological outcome after traumatic spinal cord injury. J Neurol Neurosurg Psychiatry. 2017 May;88(5):452-453. doi: 10.1136/jnnp-2016-314600. Epub 2016 Nov 18. No abstract available.
Results Reference
result
PubMed Identifier
27664973
Citation
Chen S, Phang I, Zoumprouli A, Papadopoulos MC, Saadoun S. Metabolic profile of injured human spinal cord determined using surface microdialysis. J Neurochem. 2016 Dec;139(5):700-705. doi: 10.1111/jnc.13854. Epub 2016 Oct 11.
Results Reference
result
PubMed Identifier
32435965
Citation
Hogg FRA, Kearney S, Zoumprouli A, Papadopoulos MC, Saadoun S. Acute Spinal Cord Injury: Correlations and Causal Relations Between Intraspinal Pressure, Spinal Cord Perfusion Pressure, Lactate-to-Pyruvate Ratio, and Limb Power. Neurocrit Care. 2021 Feb;34(1):121-129. doi: 10.1007/s12028-020-00988-2.
Results Reference
result
PubMed Identifier
32415143
Citation
Gallagher MJ, Hogg FRA, Kearney S, Kopp MA, Blex C, Serdani L, Sherwood O, Schwab JM, Zoumprouli A, Papadopoulos MC, Saadoun S. Effects of local hypothermia-rewarming on physiology, metabolism and inflammation of acutely injured human spinal cord. Sci Rep. 2020 May 15;10(1):8125. doi: 10.1038/s41598-020-64944-y.
Results Reference
result
PubMed Identifier
32024422
Citation
Hogg FRA, Gallagher MJ, Kearney S, Zoumprouli A, Papadopoulos MC, Saadoun S. Acute Spinal Cord Injury: Monitoring Lumbar Cerebrospinal Fluid Provides Limited Information about the Injury Site. J Neurotrauma. 2020 May 1;37(9):1156-1164. doi: 10.1089/neu.2019.6789. Epub 2020 Apr 1.
Results Reference
result
PubMed Identifier
31916236
Citation
Saadoun S, Papadopoulos MC. Targeted Perfusion Therapy in Spinal Cord Trauma. Neurotherapeutics. 2020 Apr;17(2):511-521. doi: 10.1007/s13311-019-00820-6.
Results Reference
result
PubMed Identifier
31901650
Citation
Gallagher MJ, Lopez DM, Sheen HV, Hogg FRA, Zoumprouli A, Papadopoulos MC, Saadoun S. Heterogeneous effect of increasing spinal cord perfusion pressure on sensory evoked potentials recorded from acutely injured human spinal cord. J Crit Care. 2020 Apr;56:145-151. doi: 10.1016/j.jcrc.2019.12.019. Epub 2019 Dec 23.
Results Reference
result
PubMed Identifier
30351245
Citation
Gallagher MJ, Hogg FRA, Zoumprouli A, Papadopoulos MC, Saadoun S. Spinal Cord Blood Flow in Patients with Acute Spinal Cord Injuries. J Neurotrauma. 2019 Mar 19;36(6):919-929. doi: 10.1089/neu.2018.5961. Epub 2018 Nov 16.
Results Reference
result
PubMed Identifier
30328047
Citation
Hogg FRA, Gallagher MJ, Chen S, Zoumprouli A, Papadopoulos MC, Saadoun S. Predictors of Intraspinal Pressure and Optimal Cord Perfusion Pressure After Traumatic Spinal Cord Injury. Neurocrit Care. 2019 Apr;30(2):421-428. doi: 10.1007/s12028-018-0616-7.
Results Reference
result
PubMed Identifier
30101641
Citation
Chen S, Gallagher MJ, Hogg F, Papadopoulos MC, Saadoun S. Visibility Graph Analysis of Intraspinal Pressure Signal Predicts Functional Outcome in Spinal Cord Injured Patients. J Neurotrauma. 2018 Dec 15;35(24):2947-2956. doi: 10.1089/neu.2018.5775. Epub 2018 Sep 27.
Results Reference
result
PubMed Identifier
29997566
Citation
Chen S, Gallagher MJ, Papadopoulos MC, Saadoun S. Non-linear Dynamical Analysis of Intraspinal Pressure Signal Predicts Outcome After Spinal Cord Injury. Front Neurol. 2018 Jun 26;9:493. doi: 10.3389/fneur.2018.00493. eCollection 2018.
Results Reference
result
PubMed Identifier
35029868
Citation
Visagan R, Hogg FRA, Gallagher MJ, Kearney S, Zoumprouli A, Papadopoulos MC, Saadoun S. Monitoring Spinal Cord Tissue Oxygen in Patients With Acute, Severe Traumatic Spinal Cord Injuries. Crit Care Med. 2022 May 1;50(5):e477-e486. doi: 10.1097/CCM.0000000000005433. Epub 2022 Jan 6.
Results Reference
derived

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Injured Spinal Cord Pressure Evaluation

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