The HEAT Trial was a phase 2b randomised controlled trial investigating the safety and efficacy of intravenous paracetamol versus placebo (5% dextrose) in the treatment of fever in critically ill patients with known or suspected infection.
Co-ordinated by the Medical Research Institute of New Zealand, in collaboration with the Australian and New Zealand Clinical Trials Group, the results of the trial was published in December 2015 in the New England Journal of Medicine.
This trial used our Spinnaker software to randomise patients in 22 different locations, provided a user-friendly interface for data entry (eCRF) into our enterprise database and record events (i.e. SAE) as they happened. Spinnaker also provided management tools to assist the Chief Investigator and Project Manager. These included reporting on trial progress, interim reports generated dynamically and instantly anytime needed, and management of user access to the software.
An important component of Spinnaker is the inventory module. This module was used in the HEAT Trial to manage the study drug across all 22 locations including transfers.
To hear more about how Spinnaker helped with the HEAT Trial, get in touch.
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