Introduction: Even though the last 15 years have seen a resurgence of interest in the use of decompressive craniectomy (DC) following TBI, there is still no consensus on if and when to proceed with the operation. From 2002 to 2004, two multi-centre randomised trials started recruiting patients: the DECRA trial and the RESCUEicp trial. The DECRA trial finished recruitment in 2010 (total 155 patients) and failed to show a clinical benefit with early/neuroprotective DC for patients with diffuse TBI.
Methods: The RESCUEicp trial is investigating the use of DC as a last-tier therapy for refractory raised ICP. The two arms are continuation of optimal medical management (with barbiturates) versus surgery (unilateral or bifrontal DC). Outcome is assessed using the extended Glasgow Outcome Scale and the SF-36 survey at 6, 12 and 24 months. The study is ongoing and has recruited 337 patients from more than 40 units in 17 different countries.
Results: The required sample size is 400 participants to detect a 15% difference in dichotomised outcome (power 80%, alpha 5%). The average annual recruitment since the study was awarded an MRC/NIHR clinical trials grant has been 49 patients. UK centres have recruited 69% of the patients to date. We are very keen to increase international contribution to RESCUEicp. In the last few months, four French centres and two US centres gained the necessary regulatory approvals and have now joined RESCUEicp. A trial extension until December 2014 was recently awarded to us; therefore, new sites are still welcome to join RESCUEicp.
Conclusions: DECRA and RESCUEicp have different hypotheses and inclusion criteria. Hence the DECRA results should not deter recruitment into RESCUEicp. On the other hand, the DECRA results emphasize the fact that DC remains an unproven therapy, which should ideally be undertaken in the context of randomised trials.
Patient Care: The RESCUEicp trial aims to determine whether decompressive craniectomy results in a better functional outcome compared to optimal medical management in patients with post-traumatic refractory raised ICP.
Learning Objectives: By the conclusion of this session, participants should be able to discuss the evidence-base around the management of post-traumatic refractory raised ICP.
References: Decompressive craniectomy for traumatic brain injury: the jury is still out. Hutchinson PJ, Timofeev I, Kolias AG, Corteen EA, Czosnyka M, Menon DK, Pickard JD, Kirkpatrick PJ. Br J Neurosurg. 2011 Jun;25(3):441-2
Acknowledgements: The RESCUEicp trial is supported by an MRC/NIHR Clinical Trials Grant