BONANZA: Neuromonitoring des hirnsauerstoffs in australien und neuseeland bewertung (KCE-211323)

The BONANZA trial- a randomised controlled trial that is testing whether a management strategy guided by early brain tissue oxygen monitoring in patients in with severe traumatic brain injury improves long term neurological and functional outcomes

Participants (P)

Patients who have suffered a non-penetrating severe TBI and who require ICP monitoring (in the judgement of the treating clinician).

Intervention (I)

Continuous PbtO2 and ICP monitoring. Cerebral hypoxic episodes will be treated according to the BONANZA PbtO2 optimisation strategy. The PbtO2 treatment algorithm is a set of physiologic interventions that vary depending on the clinical scenario. The physiological interventions are tiered in a hierarchical fashion, with less aggressive interventions attempted before more aggressive manoeuvres.

Control (C)

Standard care (based on ICP driven interventions alone). All patients will be managed according to a clinical standardisation guideline that reflects best international practice.

Outcome (O)

Neurological outcomes measured using the Glasgow Outcome Score - Extended (GOS-E)

Trial Design

RCT 1:1

Sample Size

860 – 210 in Belgium (up to 250)

Trial duration

66 months

Budget

1 290 000€

Australian and New Zealand Intensive Care Research Centre

School of Public Health and Preventive Medicine, Monash University

Belgian Coordinating Centre: Hôpital Erasme

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Hôpital Erasme, CHU Sart Tilman Liège, St Pierre Ottignies, UZ Gent, CHU Charleroi, Cliniques St Luc, CHR Citadelle Liege, AZ Groeninge, AZ Delta, ZOL