Randomised evaluation of surgery with craniectomie for uncontrollable elevation of intra-cranial pressure

In patients with brain injury, cerebral ischaemia and brain swelling are the
two main problems wchich occur generating a cascade of adverse metabolic events
which culminate in a cycle of further swelling, reductions in blood flow and in
oxygen and glucose supply. Therapy to reduce ICP following acute brain injury
is the cornerstone to the management of these patients. The introduction of
protocol driven therapy with a number of stages to reduce ICP has been one of
the factors leading to potential improvements in outcome.
Two surgical manoeuvres can be employed to reduce ICP:

(1) The application of external ventricular drains to drain cerebro-spinal
fluid.

(2) Decompressive craniectomy (removal of a large area of skull with opening of
the dura to increase the volume of the cranial cavity, facilitating a reduction
in ICP ).

Several reports in the literature investigate the role of decompressive
craniectomy in traumatic brain injury . These studies demonstrated a wide range
of clinical outcome, with no clear consensus regarding the indication for the
operation. The generally accepted way to resolve the role of any therapy for
neurotrauma is to obtain class I evidence by performing prospective randomised
trials. Therefore a multi-centre European trial, co-ordinated by the University
of Cambridge Department of Neurosurgery, in collaboration with the European
Brain Injury Consortium (EBIC) has been started. This trial is designed for the
following reasons:

1. Severe head injury is common and severe disability and persistent vegetative
state has profound social and economic consequences

2. The current data (small studies, class II and III evidence, poor follow up)
are inconclusive

3. A randomised study has the potential to address the concerns that the
operation does not influence the favourable outcome of good prognosis patients
and that it shifts outcome from death to vegetative state / severe disability
in poor prognosis patients.

4. To establish the incidence of complications resulting from this procedure
e.g. post-operative haematoma, infection.

The aim of this trial is to determine the effectiveness of an operation
(decompressive craniectomy), compared to medical management alone, to treat
brain swelling and improve outcome. The results of this trial will better
define the indications for treatment and the future management of these
patients with traumatic brain injury.

The study will be a randomised trial comparing optimal medical management with
surgery (decompressive craniectomy) for the management of intra-cranial
hypertension following head injury, refractory to first-line treatment.

The trial will recruit from centres experienced in the intensive care
management of head injury. The target study group will be ventilated
ICP-monitored patients with refractory intracranial hypertension. The two arms
will be the continuation of optimal medical management versus surgery
(decompressive craniectomy).

(a) for unilateral hemisphere swelling / a large unilateral
fronto-temporo-parietal craniectomy
or
(b) for bilateral diffuse hemisphere swelling a large bilateral
fronto-temporo-parietal craniectomy from the frontal sinus anteriorly to the
coronal suture posteriorly and pterion laterally with a wide dural opening
(pedicles based on the superior sagittal sinus medially and division of the
falx anteriorly).

If continued medical treatment is drawn no decompressive surgery will be
performed and therapy with highdose barbiturates will started. Eventual
decompressive surgery may be performed later at the clinician's discretion if
the patient subsequently deteriorates (for example prolonged and unacceptably
high ICP &gt40mm Hg with compromised CPP). This clause is required if a
situation arises whereby the treating physician feels that withholding surgery
is acting against the best interest of the individual - "the interests of the
patient always prevails over those of science and society". The same principle
applies to barbiturates in the decompressive craniectomy group.

As the patients who are included in the study are regarded as refractory
intracranial pressure which means that ICP does not respond to the regular
measures the outcome is expected to become fatal because of impending brain
herniation and subsequent death. The associated risks of the craniotomy such as
infection or haemorrhage in the operation area are normally low and seen in the
light of the expected fatal outcome if medical treatment is withdrawn,
neglectable.