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
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F13%3A43908054" target="_blank" >RIV/00216208:11120/13:43908054 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1097/CCM.0b013e31828e9b03" target="_blank" >http://dx.doi.org/10.1097/CCM.0b013e31828e9b03</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1097/CCM.0b013e31828e9b03" target="_blank" >10.1097/CCM.0b013e31828e9b03</a>
Alternative languages
Result language
angličtina
Original language name
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
Original language description
To determine the safety and efficacy of recombinant thrombomodulin (ART-123) in patients with suspected sepsis-associated disseminated intravascular coagulation. 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. ART-123 is a safe intervention in critically ill patientswith 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.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FI - Traumatology and orthopaedics
OECD FORD branch
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Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2013
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Critical Care Medicine
ISSN
0090-3493
e-ISSN
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Volume of the periodical
41
Issue of the periodical within the volume
9
Country of publishing house
US - UNITED STATES
Number of pages
11
Pages from-to
2069-2079
UT code for WoS article
000330537600002
EID of the result in the Scopus database
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