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A clinical trial of Immediate Cooling followed by Emergency Decompression (ICED) is underway to determine whether the combination of hypothermia and early decompression is able to improve outcomes in patients with severe spinal cord injuries of the neck. Selected patients will be cooled by paramedics or emergency physicians immediately following injury and then rapidly transported to theatre to undergo surgical decompression and stabilisation of the spinal cord. Patients will then be slowly re-warmed 24 hours following the initiation of cooling and monitored to maintain normal body temperature for a further 72 hours.

ICED is divided in two stages. Stage 1 consists of establishment of baseline data and trial techniques, while stage 2 of ICED is the main clinical trial of immediate hypothermia followed by early decompression.

The four studies involved in Stage 1 are progressing well.

The first study was a retrospective analysis of the process of care for cervical SCI patients in Australia and NZ (2010-2013), and included data from five Australian states as well as two NZ sites. To minimize the time to early decompression, it is crucial to understand and determine the duration of each step in the process of care from accident scene through to surgery. The results of this study demonstrate that the average time to decompression has improved from 31 hours in 2010 to 19 hours in 2013. The main factors contributing to delayed decompression are admission to a pre-surgical hospital and the time taken to access an operating theatre. Strategies likely to significantly reduce the time to decompression are direct admission to a spinal surgical hospital, and rapid access to the operating theatre. The results of this study were published this year in the Journal of Neurotrauma (Battistuzzo et al. 2016a).

The second study involves the development of an early rapid neurological assessment tool for determining the level of injury and severity of SCI. Because these two factors principally determine patient outcome, they are essential to determine before initiating a therapy such as hypothermia. We have developed the SPinal Emergency Evaluation of Deficits (SPEED) assessment which allows paramedics and emergency personnel to determine the level of injury and severity of SCI in minutes. SPEED appears very promising and a retrospective evaluation of the SPEED assessment has been recently published in the Journal of Neurotrauma (Battistuzzo et al. 2016b).

The third study will be a prospective validation of the SPEED assessment in a cohort of patients with suspected SCI. It is anticipated that this study will commence before the end of 2016, with recruitment in Victoria, SA and WA. Patients will be assessed by paramedics within 2 hours of their injury, and the SPEED assessment will be correlated with neurological assessments performed during acute hospital admission (< 24 hours of injury) and at 6 months after injury. This study is registered on the Australian New Zealand Clinical Trials Registry trial ID ACTRN12616000687493.

The final study of ICED Stage 1 is a safety and feasibility study of immediate cooling followed by emergency decompression. This study will determine whether it is possible to initiate mild therapeutic hypothermia (33.0-34.0oC) within 2 hours following traumatic cervical SCI and whether it is feasible to operate very early after injury. Hypothermia will be maintained for 24 hours in the Intensive Care Unit (ICU) and then patients will be slowly re-warmed over 12 hours to normal temperature. The incidence and severity of complications will be monitored to evaluate safety. Patients will otherwise receive normal ED, ICU and ward care followed by rehabilitation, with follow-up assessments at 6 months following injury. It is anticipated that the safety and feasibility study will commence in October 2016 in Victoria and run for 18-24 months.

Establishing the safety and feasibility of early hypothermia and decompression following cervical SCI is necessary before commencing a randomised clinical trial to establish the efficacy of early hypothermia and decompression (ICED Stage 2).

The ICED study has forged collaborative links across Australia and New Zealand with all spinal units participating. Centers in Victoria (Alfred Health, Austin Health and Royal Melbourne Hospital), SA (Royal Adelaide Hospital, lead investigator Professor Brian Freeman) and WA (Royal Perth Hospital, lead investigator Professor Sarah Dunlop) are participating in the prospective study of early paramedic neurological assessment.  The safety and feasibility study will commence in Victoria (Alfred Health, Austin Health).

The Spinal Network’s Clinical Trials Committee identified the potential of the ICED study to reduce the impact of spinal cord injuries and improve patient outcomes across Australia.

Dr Batchelor and fellow investigators were awarded major grant funding from the National Health and Medical Research Council and the Transport Accident Commission, through the Institution for Safety, Compensation and Recovery Research in 2014 to conduct the ICED study throughout Australia. The Spinal Cord Injury Network provided seed funding to conduct preliminary work to develop the ICED (Immediate Cooling and Early Decompression) study. 


References:

Battistuzzo, C. R., A. Armstrong, J. Clark, L. Worley, L. Sharwood, P. Lin, G. Rooke, P. Skeers, S. Nolan, T. Geragthy, A. Nunn, D. J. Brown, S. Hill, J. Alexander, M. Millard, S. F. Cox, S. Rao, A. Watts, L. Goods, G. T. Allison, J. Laurenson, P. Cameron, I. Mosley, S. M. Liew, T. Geddes, J. Middleton, J. Buchanan, J. V. Rosenfeld, S. Bernard, S. Atresh, A. Patel, R. Schouten, B. J. C. Freeman, S. A. Dunlop and P. E. Batchelor (2015). "Early Decompression following Cervical Spinal Cord Injury: Examining the Process of Care from Accident Scene to Surgery.’’ Journal of Neurotrauma.

Battistuzzo, C. R., K. Smith, P. Skeers, A. Armstrong, J. Clark, J. Agostinello, S. Cox, S. Bernard, B. J. Freeman and S. A. Dunlop (2016). "Early Rapid Neurological Assessment for Acute Spinal Cord Injury Trials." Journal of Neurotrauma.
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The Australian Spinal Cord Injury Network is excited to announce that Louise MacLellan based at the Victorian Spinal Cord Service at Austin Health has been awarded a PhD Scholarship from the Kevin Hortle Scholarship Fund. Louise’s project “Urinary complication outcomes in spinal cord injured patients following a change in hospital bladder management protocol” aims to help provide foundational research to better understand effective bladder management. Read more

Merry Christmas and Happy New Year! Read more