The RESCUEicp decompressive craniectomy study

Trauma is the commonest cause of death in patients under the age of 40 with head injury implicated in at least half the number of cases. Following injury the brain swells within a rigid box (the skull), resulting in increased pressure, reduced oxygenation and cell death. Our research (an international multi-centre randomised study - www.RESCUEicp.com) aims to determine whether patients with severe injury will benefit from an operation (decompressive craniectomy) which involves removing part of the skull bone to relieve pressure. Patients with raised pressure are randomised to receive either the operation or on-going medical treatment. The study has now recruited 126 patients from 22 centres in 8 countries out of a target of 600. The overall aim of the study is to determine whether this type of surgery reduces disability and mortality.

Head injury is a major cause of morbidity and mortality. The fundamental pathophysiological process is the development of an escalating cycle of brain swelling, increase in intra-cranial pressure (ICP), reduction in blood supply and oxygen delivery, and energy failure. This results in further swelling, enhancing brain injury and poor outcome. The management of head-injured patients is therefore directed at measuring ICP using fine transducers inserted through the skull and treating these adverse processes. In some patients this can be achieved using fundamental medical measures, with ventilation, sedation and drugs including inotropes and mannitol, but in others raised ICP becomes refractory. These patients may benefit from an operation called ‘decompressive craniectomy‘ which involves removing part of the skull and opening the dura lining the brain. There are several studies in the literature investigating the role of decompressive craniectomy in traumatic brain injury. These demonstrate a wide range of outcomes with no clear consensus regarding the indication for the operation. We have therefore commenced the pilot phase of an international multi-centre randomised trial coordinated by University of Cambridge Neurosurgery in collaboration with the European Brain Injury Consortium to investigate whether decompressive craniectomy results in improvement in outcome and surrogate endpoints compared to contemporary optimal medical management.

The trial is recruiting from centres experienced in the intensive care management of head injury. The target study group are ventilated ICP monitored patients with refractory intracranial hypertension. The inclusion criteria are patients with head injury, age 10-65 years with an abnormal CT scan requiring ICP monitoring with raised ICP (25mmHg) refractory to initial medical treatment measures. The exclusion criteria are bilateral fixed and dilated pupils, bleeding diathesis and devastating injury not expected to survive for 24 hours.

The two arms are continuation of optimal medical management (including barbiturates) versus surgery (decompressive craniectomy). Outcome is assessed using the Extended Glasgow Outcome Score at six months as the primary measure and SF-36 questionnaire, control of ICP, time in intensive care, time to discharge from the neurosurgical unit as secondary measures. The study aims to recruit 500 patients from approximately 60 centres worldwide.

The results of the study will be used to improve the design of protocols for the treatment of raised ICP following head injury, with the overall goal being to improve outcome. The pilot phase of the study has completed recruiting 50 patients from 12 centres. Further study information is available at www.RESCUEicp.com