Effect of a Recombinant Human Soluble Thrombomodulin on Baseline Coagulation Biomarker Levels and Mortality Outcome in Patients With Sepsis-Associated Coagulopathy.

Critical Care Medicine
M LeviJawed Fareed

Abstract

To assess the effects of recombinant human soluble thrombomodulin treatment on 28-day all-cause mortality in subgroups categorized by baseline coagulation biomarker levels (prothrombin fragment 1.2, thrombin-antithrombin complex, D-dimer) in patients with sepsis-associated coagulopathy in the Sepsis Coagulopathy Asahi Recombinant LE Thrombomodulin trial (SCARLET) (NCT01598831). Post hoc, subgroup analysis of a randomized, double-blind, placebo-controlled, multinational, multicenter phase 3 study. ICUs at 159 sites in 26 countries. Eight-hundred adults with sepsis-associated coagulopathy defined as international normalized ratio greater than 1.40 and platelet count between 30 × 10/L and 150 × 10/L or greater than 30% decrease within 24 hours with concomitant cardiovascular and/or respiratory failure. Patients randomized and treated with recombinant human soluble thrombomodulin (0.06 mg/kg/d; n = 395) or equivalent placebo (n = 405) for 6 days. Recombinant human soluble thrombomodulin did not significantly reduce 28-day all-cause mortality in the Sepsis Coagulopathy Asahi Recombinant LE Thrombomodulin trial: absolute risk reduction was 2.55% (p = 0.32) in patients with sepsis-associated coagulopathy. In this post hoc analysis, mo...Continue Reading

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Citations

Jan 3, 2021·International Journal of Hematology·Toshiaki IbaJerrold H Levy
Feb 9, 2021·British Journal of Haematology·Kasper AdelborgAnne-Mette Hvas
Mar 10, 2021·Critical Care : the Official Journal of the Critical Care Forum·Takashi ItoIkuro Maruyama

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Methods Mentioned

BETA
enzyme-linked immunosorbent assay
ELISA

Clinical Trials Mentioned

NCT00487656
NCT01598831

Software Mentioned

MedThink
SAS

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