CORE
🇺🇦
make metadata, not war
Services
Services overview
Explore all CORE services
Access to raw data
API
Dataset
FastSync
Content discovery
Recommender
Discovery
OAI identifiers
OAI Resolver
Managing content
Dashboard
Bespoke contracts
Consultancy services
Support us
Support us
Membership
Sponsorship
Community governance
Advisory Board
Board of supporters
Research network
About
About us
Our mission
Team
Blog
FAQs
Contact us
A randomized, double-blind, placebo-controlled, phase 2b Study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation
Authors
Naoki Aikawa
Gordon Bernard
+27 more
Daniel D.U. Blanzaco
Mark Crowther
Mradul Daga
Jacques Devriendt
David Ernest
Charles C.T. Esmon
Jawed Fareed
Kenneth K.J. Gorelick
Louis Guzzi
Seton S.J. Henderson
Joe Hirman
Eric Hoste
Inder Kaul
Demetrios James Kutsogiannis
Steven LaRosa
Marcel Levi
Howard Levy
Parthiv Mehta
Yutaka Osawa
Jan Pachl
Joseph J.E. Parrillo
Chaicharn Pothirat
Joan Vidal Puigserver
Mayakonda Krishnamurthy Ramesh
Deepak Talwar
Kazuhisa Tsuruta
Jean Louis Vincent
Publication date
1 January 2013
Publisher
Doi
Cite
Abstract
Objectives: To determine the safety and efficacy of recombinant thrombomodulin (ART-123) in patients with suspected sepsis-associated disseminated intravascular coagulation. design: Phase 2b, international, multicenter, double-blind, randomized, placebo-controlled, parallel group, screening trial. setting: Two hundred and thirty-three ICUs in 17 countries. patients: All adult patients admitted with sepsis and suspected disseminated intravascular coagulation as assessed using a modified International Society on Thrombosis and Hemostasis score. interventions: Patients were randomized to receive IV ART-123 (0.06 mg/kg/d) for 6 days or placebo, in addition to standard of care. The primary endpoint was reduction in mortality. Secondary endpoints included reversal of overt disseminated intravascular coagulation and reduction in disease severity. Measurements and main results: A total of 750 patients were randomized, nine of whom did not receive the allocated treatment so that 371 patients received ART-123 and 370 received placebo. There were no meaningful differences between the two groups in any of the baseline variables. Twenty-eight-day mortality was 17.8% in the ART-123 group and 21.6% in the placebo group (Cochran-Mantel-Haenszel two-sided p value of 0.273 in favor of ART-123, which met the predefined statistical test for evidence suggestive of efficacy). There were no statistically significant differences in event-free and alive days between the two groups. d-dimer, prothrombin fragment F1.2 and TATc concentrations were lower in the ART-123 group than in the placebo group. There were no differences between the two groups in organ function, inflammatory markers, bleeding or thrombotic events or in the development of new infections. In post hoc analyses, greatest benefit from ART-123 was seen in patients with at least one organ system dysfunction and an international normalized ratio greater than 1.4 at baseline. conclusions: ART-123 is a safe intervention in critically ill patients with sepsis and suspected disseminated intravascular coagulation. The study provided evidence suggestive of efficacy supporting further development of this drug in sepsis-associated coagulopathy including disseminated intravascular coagulation. Future study should focus on using ART-123 in the subgroup of patients most likely to respond to this agent. Copyright © 2013 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins.SCOPUS: ar.jinfo:eu-repo/semantics/publishe
Similar works
Full text
Available Versions
Crossref
See this paper in CORE
Go to the repository landing page
Download from data provider
info:doi/10.1097%2Fccm.0b013e3...
Last time updated on 25/04/2021
NARCIS
See this paper in CORE
Go to the repository landing page
Download from data provider
Last time updated on 16/12/2017
Ghent University Academic Bibliography
See this paper in CORE
Go to the repository landing page
Download from data provider
oai:archive.ugent.be:4425730
Last time updated on 12/11/2016
DI-fusion
See this paper in CORE
Go to the repository landing page
Download from data provider
oai:dipot.ulb.ac.be:2013/18806...
Last time updated on 23/02/2017