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Statement of design
TOP-TBI is a multi-centre, parallel-group, pragmatic, randomised superiority trial to determine the clinical- and cost-effectiveness of early PTP administration versus late administration for adult patients with TBI. The study will be preceded by an internal pilot to confirm recruitment, randomisation, treatment, and follow-up assessments. We have defined robust progression criteria (section 8.3) based on recently published recommendations (30). On reaching the pre-defined success criteria, the internal pilot studies will run seamlessly into the main trial.
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