University Neurosurgical Center Holland LUMC-HMC-HAGA
Prof. Dr. Peul, Dr. Valerie ter Wengel and PhD student Charlotte Adegeest of Leiden University Medical Center are setting up a nationwide study on the acute treatment of traumatic spinal cord injury. This aims to resolve ambiguities in spinal cord injury research - what is the best time to operate on a patient, and what leads to the most recovery? With the money from the 2019 race, they were able to set up the study and it has now started. This year, money raised from the Rapenburg Race will again contribute to this study so it can be expanded.
Background
Traumatic spinal cord injury (tSCI) leads to chronic disability for life and is accompanied by a lifelong risk of secondary complications as well as mortality. The STASCIS study in 2012 was one of the first which proposed a beneficial effect of early surgical decompression on neurological outcome after tSCI. However, over the past eight years the impact of surgery and its preferential interval on neurological recovery still remains unknown, primarily due to the lack of high-quality evidence. This lack of scientific evidence translates into a large practice variation worldwide, where some patients are treated very urgently within a few hours like life threatening traumatic brain injury, some between 8 and 24 hours after trauma, but mostly surgery is delayed for more than 24 hours. Due to the lifelong impact of tSCI it is necessary to investigate the impact as well as the optimal surgical timeframe in which this devastating injury can be reversed or prevented from worsening.
Methods
The study will be a prospective, multicenter study with a comparative effectiveness research (CER) design. 300 patients with traumatic spinal cord injury above 15 years old will be included. Participating centers are LUMC in Leiden, HMC and HAGA in The Hague, EMC in Rotterdam, UMCU in Utrecht, AUMC Amsterdam, UZL in Leuven, SJB in Brugge, ULB in Brussels and AZD in Roeselare and collaborating rehabilitation centers. Patients will be included from 01-07- 2022 until 01-07-2025. Each patient will receive the standard of care of each participating center. Follow-up will be 3 and 12 months after trauma with neurological examination by a trained physician and online questionnaires or by telephone/postal.
Results
The primary outcome is total motor score, as part of the ISNCSCI, 12 months after trauma. Secondary outcomes are functionality (SCIM-III), quality of life (QoL-BDS, AOProst, EuroQoL-5D) and prevalence of complications (SCI-SCS, ISAFSCI) 12 months after trauma. Motor scores, functionality, quality of life and complication measurements will also be performed three months after injury. Moreover, a cost-effectiveness, a cost-utility and safety/complication analysis will be performed.