Clinical trial NCT02721615: Injured Spinal Cord Pressure Evaluation
Official title: Evaluation of the Potential Adverse Effect of Pressure After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: intra spinal pressure
spinal cord perfusion pressure
microdialysis
duroplasty
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: Foundation Wings For Life
name: Neurosciences Research Foundation
First posted: 2016-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Intra spinal pressure
timeFrame: 0-7 days
measure: Spinal metabolites
timeFrame: 0-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's, University of London
Study officials:
affiliation: St George's, University of London
name: Marios C Papadopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.