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BRAINapt: TBI International Adaptive Platform Trial

Funding: Canadian Institutes of Health Research (CIHR)

The context

Worldwide, trauma represents an enormous health and economic burden, with over 1.4 million deaths in road accidents and staggering annual healthcare costs of $400 billion, including $29 billion in Canada alone. Most deaths are related to traumatic brain injury (TBI), which also results in severe permanent impairments and significant costs associated with the use of healthcare resources in survivors. Nevertheless, current guidelines for the management of TBI are based on limited evidence, and practice is highly variable. Standardizing evidence-based treatments is essential to improving care and outcomes for patients with TBI.

 

Our goal

We developed BRAINapt, an international patient-centered adaptive trial platform that changes the paradigm of TBI research. This innovative platform is designed to rapidly evaluate the efficacy of low-cost and readily available treatments in a real-world setting.

 

What we do

BRAINapt is an open-blinded platform trial involving multiple centers in 20 high- and middle-income countries. It is embedded in the healthcare systems of these countries and aims to improve research capacity in middle-income countries, promote sustainable healthcare systems and strengthen local healthcare services.

 

Who is eligible

We plan recruiting adult patients (18 years and older) admitted to an intensive care unit (ICU) with acute moderate or severe TBI.

 

How we conduct the study

We study different interventions within three specific families of domains: (i) drugs, (ii) devices, (iii) non drug neither device related. Patients are randomly assigned to be enrolled in one or more domains to receive one intervention or not per domain until ICU discharge or death.

 

What we measure

Our primary endpoint is the Glasgow Outcome Scale extended (GOSe), which assesses neurological outcomes at 6 months. Secondary outcomes include quality of life, cognition, depression, mortality, as well as measures such as organ-support free days, ICU-free days, ventilator-free days and adverse events.

 

What is the size of the study

We are using a Bayesian adaptive framework and will recruit patients until we reach predetermined criteria for a posterior probability of success or futility.

 

In summary

BRAINapt is an innovative effort to improve practices and outcomes for critically ill patients with TBI through an adaptive and collaborative research approach on a global scale.

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