The design of a Bayesian adaptive clinical trial of tranexamic acid in severely injured children.

ABSTRACT:

Background

Trauma is the leading cause of death and disability in children in the USA. Tranexamic acid (TXA) reduces the blood transfusion requirements in adults and children during surgery. Several studies have evaluated TXA in adults with hemorrhagic trauma, but no randomized controlled trials have occurred in children with trauma. We propose a Bayesian adaptive clinical trial to investigate TXA in children with brain and/or torso hemorrhagic trauma.

Methods/design

We designed a double-blind, Bayesian adaptive clinical trial that will enroll up to 2000 patients. We extend the traditional E_max dose-response model to incorporate a hierarchical structure so multiple doses of TXA can be evaluated in different injury populations (isolated head injury, isolated torso

SUBMITTER: VanBuren JM 

PROVIDER: S-EPMC8567588 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature