About: Efficacy of recombinant human soluble thrombomodulin for the treatment of acute exacerbation of idiopathic pulmonary fibrosis: a single arm, non-randomized prospective clinical trial

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About: Efficacy of recombinant human soluble thrombomodulin for the treatment of acute exacerbation of idiopathic pulmonary fibrosis: a single arm, non-randomized prospective clinical trial Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Efficacy of recombinant human soluble thrombomodulin for the treatment of acute exacerbation of idiopathic pulmonary fibrosis: a single arm, non-randomized prospective clinical trial
Creator	Suzuki, Yasuo Hayakawa, Sho Irie, Tamako Matsuzawa, Yasuo Okada, Noriaki Rikitake, Hagino
topic	covid:093d50972d56c14181fb88ab0612a5faecbb3e7e#this
Source	PMC
abstract	BACKGROUND: Coagulation abnormalities are involved in the pathogenesis of acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). The administration of recombinant human soluble thrombomodulin (rhTM), which has both anti-inflammatory and anticoagulant activities, improves outcomes and respiratory function in patients with acute respiratory distress syndrome. Therefore, we conducted a prospective clinical study to examine the effects of rhTM on respiratory function, coagulation markers, and outcomes for patients with AE-IPF. METHODS: After registration of the protocol, the patients with AE-IPF who satisfied the study inclusion criteria were treated daily with 380 U/kg of rhTM for 7 days and steroid pulse therapy. The concomitant administration of immunosuppressants and polymyxin B-immobilized fiber column treatment was prohibited. The sample size was 10 subjects. The primary study outcome was the improvement of PaO(2)/FiO(2) ratio a week after treatment initiation. Secondary outcomes were change in D-dimer level over time and 28-day survival rate in patients without intubation. Study data were compared with historical untreated comparison group, including 13 patients with AE-IPF who were treated without rhTM before the registration. RESULTS: The mean PaO(2)/FiO(2) ratio for the rhTM treatment group (n = 10) on day 8 significantly improved compared with that on day one (two-way analysis of variance, p = 0.01). The mean D-dimer level tended to decrease in the rhTM group on day 8, but the change was not significant. The 28-day survival rate was 50 % higher in the rhTM group than in the historical untreated comparison group, but the difference was not significant. A post hoc analysis showed that overall survival time was significantly longer in the treated group compared with that of the historical untreated comparison group (p = 0.04, log-rank test). CONCLUSION: rhTM plus steroid pulse therapy improves respiratory functions in patients with AE-IPF and is expected to improve overall patient survival without using other combination therapies. TRIAL REGISTRATION: The study was registered with University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR) in October 2012 (UMIN000009082).
has issue date	2016-11-07(xsd:dateTime)
bibo:doi	10.1186/s40248-016-0074-z
bibo:pmid	27826444
has license	cc-by
sha1sum (hex)	093d50972d56c14181fb88ab0612a5faecbb3e7e
schema:url	https://doi.org/10.1186/s40248-016-0074-z
resource representing a document's title	Efficacy of recombinant human soluble thrombomodulin for the treatment of acute exacerbation of idiopathic pulmonary fibrosis: a single arm, non-randomized prospective clinical trial
has PubMed Central identifier	PMC5098285
has PubMed identifier	27826444
schema:publication	Multidiscip Respir Med
resource representing a document's body	covid:093d50972d56c14181fb88ab0612a5faecbb3e7e#body_text
is http://vocab.deri.ie/void#inDataset of	proxy:http/ns.inria.fr/covid19/093d50972d56c14181fb88ab0612a5faecbb3e7e
is schema:about of	named entity 'acute' named entity 'function' named entity 'acute respiratory distress syndrome' named entity 'clinical study' named entity 'clinical trial' named entity 'prospective' named entity 'arm' named entity 'acute exacerbation' named entity 'ADMINISTRATION' named entity 'IPF' named entity 'CLINICAL STUDY' named entity 'TO EXAMINE' covid:arg/093d50972d56c14181fb88ab0612a5faecbb3e7e named entity 'recombinant' named entity 'exacerbations' named entity 'acute exacerbations' named entity 'recombinant' named entity 'coagulation' named entity 'anti-inflammatory' named entity 'anticoagulant' named entity 'respiratory function' named entity 'pathogenesis' named entity 'Coagulation abnormalities' named entity 'respiratory function' named entity 'recombinant' named entity 'thrombomodulin' named entity 'RECOMBINANT' named entity 'idiopathic pulmonary fibrosis' named entity 'thrombomodulin' named entity 'acute exacerbation' named entity 'clinical study' named entity 'ANTICOAGULANT' named entity 'SOLUBLE' named entity 'OUTCOMES' named entity 'PATHOGENESIS' named entity 'ACUTE EXACERBATIONS' named entity 'HUMAN' named entity 'ACUTE RESPIRATORY DISTRESS SYNDROME' named entity 'MARKERS' named entity 'COAGULATION' named entity 'PATIENTS' named entity 'RECOMBINANT' named entity 'ACUTE EXACERBATION OF IDIOPATHIC PULMONARY FIBROSIS' named entity 'acute respiratory distress syndrome' named entity 'IDIOPATHIC PULMONARY FIBROSIS' named entity 'clinical trial' named entity 'idiopathic pulmonary fibrosis' named entity 'administration' named entity 'involved' named entity 'respiratory' named entity 'patients' named entity 'function' named entity 'Coagulation' named entity 'coagulation' named entity 'activities' named entity 'conducted' named entity 'patients' named entity 'idiopathic pulmonary fibrosis' named entity 'Efficacy' named entity 'recombinant' named entity 'human' named entity 'anti-inflammatory' named entity 'abnormalities' named entity 'pathogenesis' named entity 'prospective' named entity 'respiratory' named entity 'thrombomodulin' named entity 'Therefore' named entity 'idiopathic pulmonary fibrosis' named entity 'EFFECTS' named entity 'ANTI-INFLAMMATORY' named entity 'THROMBOMODULIN' named entity 'IMPROVES' named entity 'INVOLVED'

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