Trial reportBMJ open2016
Can recombinant human thrombomodulin increase survival among patients with severe septic-induced disseminated intravascular coagulation: a single-centre, open-label, randomised controlled trial.
Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 46 citations in OpenAlex.
- Clinical practice guidelines for management of disseminated intravascular coagulation in Japan 2024. Part 1: sepsis.International journal of hematology · 2025Guideline
- The efficacy of recombinant human soluble thrombomodulin (rhsTM) treatment for acute exacerbation of idiopathic pulmonary fibrosis: a systematic review and meta-analysis.BMC pulmonary medicine · 2020Pooled it
- Effect of Anticoagulant Versus Non-Anticoagulant Therapy on Mortality of Sepsis-Induced Disseminated Intravascular Coagulation: A Systematic Review and Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisPooled it
- Efficacy and safety of anticoagulant therapy in patients with sepsis: a meta-analysis of randomized controlled trials.Thrombosis journal · 2025Article
- The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2024.Journal of intensive care · 2025Article
- The transition of the criteria for disseminated intravascular coagulation and the targeted patients in randomized controlled trials over the decades: a scoping review.Thrombosis journal · 2024Article
- Targeting the host response in sepsis: current approaches and future evidence.Critical care (London, England) · 2023Review
- Endothelial dysfunction and immunothrombosis in sepsis.Frontiers in immunology · 2023Review
- Prognostic factors in patients with septic disseminated intravascular coagulation treated with thrombomodulin: the effect of reduced thrombomodulin dose; a single-center, retrospective, observational study.Journal of pharmaceutical health care and sciences · 2022Article
- Signaling pathways and intervention therapies in sepsis.Signal transduction and targeted therapy · 2021Review
- The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J-SSCG 2020).Journal of intensive care · 2021Article
- Recombinant thrombomodulin protects against LPS-induced acute respiratory distress syndrome via preservation of pulmonary endothelial glycocalyx.British journal of pharmacology · 2020Article
- Beneficial effect modification on survival outcome of sepsis between ART-123 and polymyxin B‑immobilised haemoperfusion: a nationwide Japanese registry study.Annals of intensive care · 2020Article
- Thrombomodulin in disseminated intravascular coagulation and other critical conditions-a multi-faceted anticoagulant protein with therapeutic potential.Critical care (London, England) · 2019Review
- Recombinant Human-Soluble Thrombomodulin Contributes to Reduced Mortality in Sepsis Patients With Severe Respiratory Failure: A Retrospective Observational Study Using a Multicenter Dataset.Shock (Augusta, Ga.) · 2019Observational
- Sepsis: Inflammation Is a Necessary Evil.Frontiers in cell and developmental biology · 2019Review
- Effects of combination therapy using antithrombin and thrombomodulin for sepsis-associated disseminated intravascular coagulation.Annals of intensive care · 2017Article
- The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2024.Acute medicine & surgeryArticle
- Epidemiology of sepsis in a Japanese administrative database.Acute medicine & surgeryReview
- The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2020 (J-SSCG 2020).Acute medicine & surgeryArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine whether treatment with recombinant human thrombomodulin (rhTM) increases survival among patients with severe septic-induced disseminated intravascular coagulation (DIC).
designSingle-centre, open-label, randomised controlled trial.
settingSingle tertiary hospital. PARTICIPANT: 92 patients with severe septic-induced DIC.
interventionsPatients with DIC scores ≥4, as defined by the Japanese Association of Acute Medicine, were diagnosed with DIC. The envelope method was used for randomisation. The treatment group (rhTM group, n=47) was intravenously treated with rhTM within 24 hours of admission (day 0), and the control group (n=45) did not receive any anticoagulants, except in cases of deep venous thrombosis and pulmonary embolism. PRIMARY AND SECONDARY MEASUREMENTS: Data were collected on days 0 (admission), 1, 2, 3, 5, 7 and 10. The primary outcome was survival at 28 and 90 days. The secondary end points comprised changes in DIC scores, platelet counts, d-dimer, antithrombin III and C reactive protein levels, and Sequential Organ Failure Assessment (SOFA) scores. All analyses were conducted on an intent-to-treat basis. MAIN
resultsThe 28-day survival rates were 84% and 83% in the control and rhTM groups, respectively (p=0.745, log-rank test). The 90-day survival rates were 73% and 72% in the control and rhTM groups, respectively (p=0.94, log-rank test). Meanwhile, the rates of recovery from DIC (<4) were significantly higher in the rhTM group than in the control group (p=0.001, log-rank test). Relative change from baseline of d-dimer levels was significantly lower in the rhTM group than in the control group, on days 3 and 5.
conclusionsrhTM treatment decreased d-dimer levels and facilitated DIC recovery in patients with severe septic-induced DIC. However, the treatment did not improve survival in this cohort. TRIAL REGISTRATION NUMBER: UMIN000008339.
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