DECRA Trial (DECompressive CRAniectomy Trial)
Multi-Centre Prospective Randomised Trial of Early Decompressive
Craniectomy in Patients with Severe Traumatic Brain Injury
Chief Investigator: Professor Jamie Cooper
Lead Organisation: Bayside Health
TAC Neurotrauma Funding: $89,769
Project Start Date: 1 January 2008- 29 June 2011
Background:
Severe head injury is the major cause of death in trauma patients admitted to hospital,
and with current best practice, results in only about one third of patients able to live
independently in the long term. The rest are severely disabled (lifetime cost of $2.5
million each) or dead. Brain swelling in the days after injury increases the severity of
brain injury and the usual control measures in intensive care are often ineffective.
Decompressive craniectomy is a surgical operation to decrease brain pressures, which
has been used with increasing frequency. Clinicians however do not know whether
the operation achieves its goal of improving patient outcomes. The question is
considered of great importance internationally. We tested the concept in the highest
quality randomised clinical trial in centres in Australia, NZ and internationally.
Aims:
To determine if early decompressive craniectomy improves neurological outcomes in
patients with severe diffuse traumatic brain injury and early refractory intracranial
hypertension
Methods:
Patients with severe diffuse traumatic brain injury and brain swelling that did not
respond to standard medical care were considered for the trial. Consent was obtained
from the next of kin. Patients were then randomised to receive best medical care
(including drugs to place the patient in a deeper coma) or decompressive craniectomy
and best medical care. The decompressive craniectomy involved removing a large
piece of the frontal bone, storing it in the freezer and replacing at a later date when the
brain swelling had subsided. Data was collected about the patient’s injury and
management and they were followed up at 6 & 12 months to assess their functional
outcome.
Results:
The trial was conducted between December 2002 and April 2010. One hundred and
fifty five patients from Australia, New Zealand and Saudi Arabia were randomized;
73 were assigned to craniectomy and 82 to best medical care. The two groups had
similar characteristics such as type and severity of injury. The patients in the
decompressive craniectomy group had better control of their brain swelling as
measured by the Intracranial pressure (ICP) and required less medications to control
the brain swelling. They spent less time receiving mechanical assistance with
breathing and less time in ICU. However at 6 months the decompressive craniectomy
group had a poorer outcome with a greater proportion of patients not able to live
independently in the community.
Conclusion:
In adults with severe diffuse traumatic brain injury and brain swelling, early
decompressive craniectomy decreased the intracranial pressure and length of stay in
Intensive Care but increased unfavourable outcomes.
Publications:
ROSENFELD JV, COOPER J. What is the role for decompressive craniectomy in severe traumatic
brain injury? Re: Decompressive craniectomy surgical control of intracranial hypertension may
improve outcome Injury. 2010;41(9):899-900.
COOPER DJ, ROSENFELD JV. Does decompressive craniectomy improve outcomes in patients with
diffuse traumatic brain injury? New results from an Australian collaborative randomised trial will
change practice. Med J Aust. 2011;194(9):437-438.
COOPER DJ, ROSENFELD JV, MURRAY L, ARABI YM, DAVIES AR, D'URSO P, KOSSMANN
T, PONSFORD J, SEPPELT I, REILLY P, WOLFE R; the DECRA Trial Investigators and the
Australian and New Zealand Intensive Care Society Clinical Trials Group. Decompressive
Craniectomy in Diffuse Traumatic Brain Injury. N Engl J Med. 2011;364(16):1493-502.
COOPER DJ, ROSENFELD JV, MURRAY L, WOLFE R, PONSFORD J, DAVIES A, D’URSO P,
PELLEGRINO V, MALHAM G, KOSSMANN T. Early decompressive craniectomy for patients with
severe traumatic brain injury and refractory intracranial hypertension- a pilot randomised trial. J Crit
Care. 2008;23(3):387-93.
Presentations:
COOPER DJ. Extreme organ support – Lid on or Lid off?. College of Intensive Care Medicine Annual
Scientific Meeting; 2011 June 2, Canberra, Australia.
COOPER DJ. Decompressive strategies in Traumatic Brain Injury (TBI) and Spinal Cord Injury- The
Australian Experience in TBI. 10th International Neurotrauma Symposium; 2011 April, Beijing, China.
ROSENFELD JV. Early decompressive craniectomy for patients with severe traumatic brain injury and
refractory intracranial hypertension (DECRA)- a randomised clinical trial. American Association of
Neurosurgeons 79th Annual Scientific Meeting; 2011 April, Denver, USA.
COOPER DJ. Early decompressive craniectomy for patients with severe traumatic brain injury and
refractory intracranial hypertension (DECRA) – a randomised clinical trial. 31st International
Symposium on Intensive Care & Emergency Medicine; 2011 March, Brussels, Belgium.
ROSENFELD JV. Decompressive Craniectomy: the Australian DECRA study: where are we? 2nd
International Congress of Asia Oceania Neurotrauma Society. Tokyo Station Conference; 2010 March,
Tokyo, Japan.
ROSENFELD JV. A multi-centred trial of early decompressive craniectomy in patients with severe
traumatic brain injury (DECRA) XIV. World Congress of Neurological Surgery; 2009 September,
Boston, USA.
MURRAY LJ, COOPER JD, ROSENFELD JV, ARABI Y, DAVIES A, D’URSO P, KOSSMANN T,
PONSFORD J, REILLY P, SEPPELT I, WOLFE R, VALLANCE S, HOWE B, ALKISHI M.
Optimising follow up and outcome assessments in traumatic brain injury trials 10th International
Neurotrauma Symposium; 2011 April, Beijing, China.
MURRAY LJ, COOPER DJ, ROSENFELD JV, ARABI Y, DAVIES A, D’URSO P, KOSSMANN T,
PONSFORD J, REILLY P, SEPPELT I, WOLFE R, VALLANCE S, HOWE B, ALKISHI M.
Optimising follow up and outcome assessments in severe traumatic brain injury trials. 31st
International Symposium on Intensive Care and Emergency Medicine; 2011 March 22-25, Brussels,
Belgium.
MURRAY LJ, COOPER DJ, ROSENFELD JV, ARABI Y, DAVIES A, D’URSO P, KOSSMANN T,
PONSFORD J, REILLY P, SEPPELT I, WOLFE R. Optimising the consent process in traumatic brain
injury trials. 31st International Symposium on Intensive Care and Emergency Medicine; 2011 March
22-25, Brussels, Belgium.