Recombinant human soluble thrombomodulin and mortality in severe pneumonia patients with sepsis‐associated disseminated intravascular coagulation: an observational nationwide study. (11th December 2014)

• Record Type: Journal Article
• Authors: Tagami, T.; Matsui, H.; Horiguchi, H.; Fushimi, K.; Yasunaga, H.
• Is Part Of: Journal of thrombosis and haemostasis. Volume 13:Number 1(2015:Jan.)
• Page Start: 31
• Page End: 40
• Publication Date: 2014-12-11
• Subjects: Thrombosis -- Periodicals; Hemostasis -- Periodicals; Blood coagulation disorders -- Periodicals; 616.1
• DOI: 10.1111/jth.12786
• Languages: English
• ISSNs: 1538-7933

Abstract

<abstract abstract-type="main" id="jth12786-abs-0001"> <title>Summary</title> <sec id="jth12786-sec-0001" sec-type="section"> <title>Background</title> <p>The association between recombinant human soluble thrombomodulin (rhTM) use and mortality in patients with sepsis‐associated disseminated intravascular coagulation (DIC) remains controversial.</p> </sec> <sec id="jth12786-sec-0002" sec-type="section"> <title>Objectives</title> <p>To examine the hypothesis that rhTM could be effective in the treatment of patients with sepsis‐associated DIC following severe pneumonia.</p> </sec> <sec id="jth12786-sec-0003" sec-type="section"> <title>Methods</title> <p>Propensity score and instrumental variable analyses using a nationwide administrative database, the Japanese Diagnosis Procedure Combination inpatient database, were used. The main outcome was 28‐day in‐hospital all‐cause mortality.</p> </sec> <sec id="jth12786-sec-0004" sec-type="section"> <title>Results</title> <p>Eligible patients (<italic>n</italic> = 6342) from 936 hospitals were categorized into the rhTM group (<italic>n</italic> = 1280) or control group (<italic>n</italic> = 5062). Propensity score matching created a matched cohort of 1140 pairs with and without rhTM. No significant difference in 28‐day mortality was documented between the two groups in the unmatched analysis (rhTM vs. control, 37.0%, 474/1280 vs. 36.9%, 1866/5062; odds ratio [OR], 1.00; 95%CI, 0.98–1.03), nor in the propensity‐matched analysis (37.6%, 429/1140 vs. 37.0%, 886/1140; OR, 1.01; 95%CI, 0.93–1.10). The logistic regression analysis did not show a significant association between the use of rhTM and 28‐day mortality in propensity‐matched patients (OR, 1.00; 95%CI, 0.87–1.22). An analysis using the hospital rhTM‐prescribing rate as an instrumental variable found that receipt of rhTM was not associated with reduction in mortality at 28 days (risk difference, 0.008; 95% CI, −0.08–0.98).</p> </sec> <sec id="jth12786-sec-0005" sec-type="section"> <title>Conclusions</title> <p>This large retrospective nationwide study demonstrated that there might be little association between the use of rhTM and mortality in severe pneumonia patients with sepsis‐associated DIC. A multinational randomized trial is required to confirm this.</p> </sec> </abstract>