Decompressive craniectomy following traumatic brain injury: developing the evidence base

Abstract

In the context of traumatic brain injury (TBI), decompressive craniectomy (DC) is used as part of tiered therapeutic protocols for patients with intracranial hypertension (secondary or protocol-driven DC). In addition, the bone flap can be left out when evacuating a mass lesion, usually an acute subdural haematoma (ASDH), in the acute phase (primary DC). Even though, the principle of “opening the skull” in order to control brain oedema and raised intracranial pressure has been practised since the beginning of the 20th century, the last 20 years have been marked by efforts to develop the evidence base with the conduct of randomised trials. This article discusses the merits and challenges of this approach and provides an overview of randomised trials of DC following TBI. An update on the RESCUEicp study, a randomised trial of DC versus advanced medical management (including barbiturates) for severe and refractory post-traumatic intracranial hypertension is provided. In addition, the rationale for the RESCUE-ASDH study, the first randomised trial of primary DC versus craniotomy for adult head-injured patients with an ASDH, is presented.

KEYWORDS:

• Acute subdural haematoma
• brain oedema
• clinical trial
• intracranial pressure
• traumatic brain injury

Acknowledgements

We would like to thank the members of the British Neurosurgical Trainee Research Collaborative (www.bntrc.org.uk) and British Neurotrauma Group (www.ukneurotrauma.org.uk) collaborating on the RESCUE-ASDH study. We would also like to thank all the members of the RESCUEicp and RESCUE-ASDH Collaborative Groups, Trial Steering Committees and Data Monitoring and Ethics committees. The RESCUE-ASDH trial is an “embedded study” linked with the CENTER-TBI project (https://www.center-tbi.eu/) of the European Brain Injury Consortium. AGK is the IDEAL Collaboration Specialty Lead for Neurosurgery (http://www.ideal-collaboration.net/). PJH is supported by an NIHR Research Professorship, the NIHR Cambridge Biomedical Research Centre, and is the Neurosurgical Specialty Lead, Royal College of Surgeons of England Clinical Research Initiative.

Disclosure statement

The authors alone are responsible for the content and writing of the paper. The authors are involved as investigators with the RESCUEicp and RESCUE-ASDH trials. The views expressed in this publication are those of the authors and not necessarily those of the MRC, NHS, NIHR or the Department of Health.

Funding statement

The RESCUEicp study is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and National Institute for Health Research (NIHR) partnership (project number 09/800/16). The RESCUE-ASDH study is funded by the NIHR Health Technology Assessment programme (project number 12/35/57).