Updates on studies using Spinnaker Dec 2020
- ASCOT ADAPT opened for enrolments in India this week. The trial will generate clinical evidence about treatment for COVID-19 that can be applied during the pandemic, to reduce mortality or the need for mechanical ventilation in hospitalised but not yet critically ill patients with COVID-19.
- Mega-ROX began enrolling patients in May and has over 500 patients enrolled in New Zealand, Japan and Saudi Arabia. With a goal of enrolling over 40,000 patients, this is going to be a mammoth study. The trial is comparing conservative vs. liberal oxygenation targets in mechanically ventilated adults in intensive care.
- PLUS has reached 5,000 enrolments and is closing at the end of the year. This trial is testing whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation, when compared to the same treatment with 0.9% sodium chloride (saline).
- REMAP-CAP Covid-19 brought immense challenges to everyone in 2020, and it brought us our greatest challenge ever: adapting our Spinnaker platform to manage the world’s most complex clinical trial – a trial that tackled Covid-19 head-on. At the time of writing this the REMAP-CAP trial has over 3,500 patients enrolled, in over 15 countries, at 300 sites around the world.
- SNAP is our latest study out of the gate and still in the early development stage. It’s a clinical trial for golden staph bloodstream infections. SNAP aims to improve treatment outcomes for patients with common, but deadly, golden staph bloodstream infections.
- TTM2 has completed enrolments. 1,900 patients randomised – bra gjort! (That’s well done in Sweden, which is mission control for the study.) TTM2 is investigating whether targeted temperature management (TTM) to 33°C improves survival and neurological outcome at 6 months, compared to a strategy of targeting normothermia and avoiding fever above 37.7°C for cardiac patients admitted to intensive care.
- TAME has enrolled over 1,200 patients, which is an epic achievement in the middle of a pandemic. TAME is also looking at cardiac patients admitted to intensive care, and investigating if targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia) (TN).