Spinal Cord InjuriesISCoPENCT02721615
Injured Spinal Cord Pressure Evaluation
A study testing Insertion of intra spinal sub dural pressure monitor and Insertion of sub dural microdialysis probe in people with Spinal Cord Injuries, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Insertion of intra spinal sub dural pressure monitor and Insertion of sub dural microdialysis probe
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Concurrent major co-morbidity likely to influence outcome Other major concurrent injury likely to influence outcome
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St George's, University of London
London, SW17 0RE
Marios C Papadopoulos, MD, 0208 7254179, mpapadop@sgul.ac.uk
Samira Saadoun, PhD, 0208 7254179, ssaadoun@sgul.ac.uk
About this study
Official title: 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.
Read more
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Insertion of intra spinal sub dural pressure monitor, Insertion of sub dural microdialysis probe
- Keywords
- intra spinal pressure, spinal cord perfusion pressure, microdialysis, duroplasty
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of intra spinal sub dural pressure monitorProcedure or surgery
Also called codman microsensor transducer. Ref. 626638
Insertion of sub dural microdialysis probeProcedure or surgery
Also called CMA61, CMA microdialysis AB. Ref.8010226
| Study group | Role | What they receive |
|---|---|---|
| Laminectomy | Active comparator | Comparison of bone decompression versus no decompression for reducing intra spinal pressure Receives: Procedure: Insertion of intra spinal sub dural pressure monitor |
| Duraplasty | Active comparator | Expansion duraplasty versus no duraplasty for reducing intraspinal pressure Receives: Procedure: Insertion of intra spinal sub dural pressure monitor; Procedure: Insertion of sub dural microdialysis probe |
| Hypothermia | Active comparator | Localised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism Receives: Procedure: Insertion of intra spinal sub dural pressure monitor; Procedure: Insertion of sub dural microdialysis probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra spinal pressure
Intra spinal pressure measured for up to 7 days using sub dural probe
Measured: 0-7 days
Spinal metabolites
Spinal cord metabolites measured using microdialysis probe
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startSep 2010
- Primary completionSep 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life, Neurosciences Research Foundation
- Responsible party
- Sponsor
- Investigators
- Marios C Papadopoulos, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721615
- Sponsor's protocol ID
- 09.0151
- Other IDs
- 10/H0807/23
- Acronym
- ISCoPE
- Status last verified
- Dec 2020
- First submitted
- 17 Mar 2016
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21939394Phang 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.
PubMed 26641852Varsos 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.
PubMed 26273764Phang 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.
PubMed 26136148Phang 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.
PubMed 25705999Werndle 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.
PubMed 24231762Gallagher 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.
PubMed 29629987Chen 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.
PubMed 28351230Saadoun 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.
PubMed 27864426Chen 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.
PubMed 27664973Hogg 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.
PubMed 32435965Gallagher 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.
PubMed 32415143Hogg 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.
PubMed 32024422Saadoun S, Papadopoulos MC. Targeted Perfusion Therapy in Spinal Cord Trauma. Neurotherapeutics. 2020 Apr;17(2):511-521. doi: 10.1007/s13311-019-00820-6.
PubMed 31916236Gallagher 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.
PubMed 31901650
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Potential Adverse Effect of Pressure After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02721615
- Acronym / sponsor ID
- ISCoPE / 09.0151
- Conditions
- Spinal Cord Injuries
- Keywords
- intra spinal pressure, spinal cord perfusion pressure, microdialysis, duroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- Foundation Wings For Life, Neurosciences Research Foundation
- Study start
- Sep 2010
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laminectomy | Active comparator | Procedure: Insertion of intra spinal sub dural pressure monitorComparison of bone decompression versus no decompression for reducing intra spinal pressure |
| Duraplasty | Active comparator | Procedure: Insertion of intra spinal sub dural pressure monitor, Procedure: Insertion of sub dural microdialysis probeExpansion duraplasty versus no duraplasty for reducing intraspinal pressure |
| Hypothermia | Active comparator | Procedure: Insertion of intra spinal sub dural pressure monitor, Procedure: Insertion of sub dural microdialysis probeLocalised hypothermia for reducing intra spinal pressure and improving spinal cord metabolism |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Concurrent major co-morbidity likely to influence outcome Other major concurrent injury likely to influence outcome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion of intra spinal sub dural pressure monitorAlso: codman microsensor transducer. Ref. 626638 | Procedure or surgery | Duraplasty, Hypothermia, Laminectomy |
| Insertion of sub dural microdialysis probeAlso: CMA61, CMA microdialysis AB. Ref.8010226 | Procedure or surgery | Duraplasty, Hypothermia |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Background: PubMed 21939394Werndle 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 publication: PubMed 26641852Phang 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 publication: PubMed 26273764Varsos 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 publication: PubMed 26136148Phang 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 publication: PubMed 25705999Phang 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 publication: PubMed 24231762Werndle 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 publication: PubMed 29629987Gallagher 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 publication: PubMed 28351230Chen 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 publication: PubMed 27864426Saadoun 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 publication: PubMed 27664973Chen 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 publication: PubMed 32435965Hogg 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 publication: PubMed 32415143Gallagher 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marios C Papadopoulos, MD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of intra spinal sub dural pressure monitor and Insertion of sub dural microdialysis probe in people with Spinal Cord Injuries, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marios C Papadopoulos, MD (0208 7254179, mpapadop@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra spinal pressure (time frame: 0-7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721615, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.