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The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission.
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The primary objective of this study is to use HBP concentration to indicate the presence, or outcome, of severe sepsis (including septic shock) at admission and to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission.
The secondary objectives of this study are to separately evaluate the performance of HBP concentration to a) indicate the presence of severe sepsis (including severe sepsis) at admission and b) to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission.
Further exploratory objectives include evaluating the use of HBP measurement to indicate the outcome of severe sepsis (including septic shock) in patients with suspected infection 12-24 hours after emergency department admission, to compare the use of HBP to other markers of severe infection and to evaluate whether or not different cut-off values are required for the progression and outcome measures.
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Data sourced from clinicaltrials.gov
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