Brain Injuries, Traumatic Clinical Trial
Official title:
A Randomized Clinical Trial Assessing the Effect of "Optimal" Cerebral Perfusion Pressure Monitoring in the Management of Severe Traumatic Brain Injury
Despite improvements in management, mortality in severe traumatic brain injury (TBI) remains
25% and only 40% of patients survive without major handicap. Medical/surgical interventions
aim to maintain adequate brain perfusion, which is critically dependent on cerebral perfusion
pressure (CPP); calculated as the difference between mean arterial pressure (MAP) and
intracranial pressure (ICP). Current guidelines aim for a CPP above 50 mmHg, based on
population means. However, this 'one size fits all' approach is flawed, because the relation
between CPP and brain perfusion varies between individuals. Further, this approach takes no
account of autoregulation, a key protective mechanism that maintains cerebral perfusion
despite CPP fluctuations.
Autoregulation is variably preserved following TBI, and there are large between patient
variances in the 'optimal' CPP (CPPopt) at which autoregulation operates best. Individual
CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a
certain time window. The investigators have shown that maintenance of CPP close to CPPopt is
associated with improved outcomes. These data pose the hypothesis that optimisation of
management in individuals may be achieved by using the zone of optimal autoregulation as a
basis for defining individualised CPP targets.
The investigators propose, together with collaborators in the CPPopt study group (Maastricht,
Cambridge, Leuven and Aachen) to set up a pilot (multicenter) feasibility study to develop a
protocol for a definitive outcome randomized controlled trial (RCT). This study aims to
develop protocols for CPPopt guided critical care, and show that they maintain patients
closer to their optimum perfusion levels than standard protocols which keep above a
population CPP threshold of 60 mmHg.
Hence, the main objective is to offer clinicians monitoring and therapy algorithms that
achieve individualized optimal CPPopt targets and potentially improve TBI outcome.
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