Introduction Intracranial hypertension is considered as an independent risk factor
of mortality and neurological disabilities after severe traumatic brain injury (TBI).
However, clinical studies have demonstrated that episodes of brain ischaemia/hypoxia
are common despite normalisation of intracranial pressure (ICP). This study assesses
the impact on neurological outcome of guiding therapeutic strategies based on the
monitoring of both brain tissue oxygenation pressure (PbtO(2)) and ICP during the
first 5 days following severe TBI. Methods and analysis Multicentre, open-labelled,
randomised controlled superiority trial with two parallel groups in 300 patients with
severe TBI. Intracerebral monitoring must be in place within the first 16 hours post-trauma.
Patients are randomly assigned to the ICP group or to the ICP + PbtO(2)group. The
ICP group is managed according to the international guidelines to maintain ICP <=
20 mm Hg. The ICP + PbtO(2)group is managed to maintain PbtO(2)>= 20 mm Hg in addition
to the conventional optimisation of ICP. The primary outcome measure is the neurological
status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary
outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity
and incidence of critical events during the first 5 days. Analysis will be performed
according to the intention-to-treat principle and full statistical analysis plan developed
prior to database freeze. Ethics and dissemination This study has been approved by
the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency
for Medicines and Health Products Safety (Agence Nationale de Securite du Medicament
et des produits de sante) (141 435B-31). Results will be presented at scientific meetings
and published in peer-reviewed publications. The study was registered with ClinTrials
NCT02754063 on 28 April 2016 (pre-results).