Safety and feasibility trial of immediate cooling followed by early decompression in patients with cervical SCI; a substudy of the ICED trial
Establishing the safety and feasibility of early hypothermia and decompression following cervical SCI is necessary before commencing a phase 3 randomised clinical trial to establish the combined efficacy of early hypothermia and decompression (ICED trial).This phase 2 clinical trial will determine whether it is feasible and safe to initiate mild therapeutic hypothermia ( 33-34°C) within 2 hours following traumatic cervical SCI in patients who undergo early decompression ≤18 hours.
The initial assessment in the pre-hospital setting will be the SPEED (SPinal Emergency Evaluation of Deficits) assessment, designed to rapidly establish the level and severity of cervical SCI. After initial assessment and confirmation of suspected SCI, patients will undergo CT/MRI scanning followed by (if indicated) surgical decompression of the spinal cord as soon as possible and ≤18 hours post-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. Patients will otherwise receive normal ED, ICU and ward care followed by rehabilitation. Core temperatures, time to surgery, complications and outcomes in this study group will be compared with a control group of normothermic patients with cervical SCI who have been treated at The Alfred hospital over the last 4 years and who have undergone early decompressive surgery.
Safety will be established by comparing the incidence and severity of complications in hypothermic and historical normothermic patients . Feasibility will be determined by the ability ro undertake very early decompression in patients with cervical SCI within target timeframes.
- Dr. Peter Batchelor, Senior Lecturer
- Dr. Camila Battistuzzo, Post-Doctoral Research Fellow
- Peta Skeers, Research Assistant
- Ambulance Victoria
- Alfred Health
- Immediate Cooling and Emergency Decompression (ICED) for the treatment of spinal cord injury: pilot, safety and feasibility studies (Neurotrauma-Funding Provider Project) awarded by Institute for Safety, Compensation and Recovery Research (ISCRR)
- Immediate Cooling and Emergency Decompression (ICED) for the treatment of spinal cord injury: pilot, safety and feasibility studies (Project Grant) awarded by NHMRC
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