The Mechanisms of Aspirin Therapy in Sepsis [MATHS] trial

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Background: Despite the high burden of mortality of sepsis, there are no clearly effective strategies to suppress the underlying inflammatory response. Studies have suggested that low-dose aspirin - a cost-effective and safe medication - has a potential role in the prevention and treatment of sepsis. This trial aims to measure the effects of low-dose aspirin on target inflammatory markers; activation of NF-KB, increases in aspirin triggered lipoxins (ATLs) pathway, platelet activation indices, immune cellular markers and the rate of organ dysfunction in septic patients. Method: The MATHS trial is a single-centre, randomised, open label, phase II trial. One hundred and thirty-five septic patients (Sepsis-3 definition) will be randomised to one of three treatment groups: aspirin 100mg, aspirin 300mg both given daily for two days or no treatment. Blood samples will be taken at regular set intervals and assays will be performed to quantify the inflammatory response via NF-KB activation, expression of aspirin triggered lipoxins (ATLs) and various other inflammatory markers. Initial SOFA and APACHE II scores will be calculated, with repeat SOFA scores at 24 and 48 hours. Exploratory analyses, such as the correlation between ATL levels at 24 hours, and deterioration in SOFA scores/mortality/length of stay in ICU, will involve exact tests for comparisons of categorical outcomes (SOFA), log ranked tests for non-parametric data (APACHE II) and ordinal logistic regression for multivariable analysis. Conclusions: The results of this this trial could add further evidence to support the use of low-dose aspirin in sepsis.

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