Addition of recommendations for the use of recombinant human thrombomodulin to the “Expert consensus for the treatment of disseminated intravascular coagulation in Japan”

Wada, Hideo; Okamoto, Kohji; Iba, Toshiaki; Kushimoto, Shigeki; Kawasugi, Kazuo; Gando, Satoshi; Madoiwa, Seiji; Uchiyama, Toshimasa; Mayumi, Toshihiko; Seki, Yoshinobu

doi:10.1016/j.thromres.2014.07.033

Cited by 35 publications

(30 citation statements)

References 10 publications

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“…Anti‐thrombin (AT) was within the normal range (Table ). These laboratory data were consistent with a diagnosis of DIC, in accordance with the Japanese Ministry of Health and Welfare DIC scoring system (total score of 8 points, not including bleeding and platelet count affected by AML‐related myelosuppression) . Recombinant thrombomodulin (rTM) and fresh frozen plasma were given daily for the near‐undetectable low Fbg.…”

Section: Methodssupporting

confidence: 63%

“…This novel agent seems to mediate fewer hemorrhagic side-effects than low-molecularweight heparin and improves overall survival. [20][21][22] Daily rTM from admission, however, failed to prevent severe epistaxis in the present young patient. Combination therapy using nafamostat mesilate or heparin and TXA may be dramatically effective for severe bleeding in patients with DIC and enhanced fibrinolysis.…”

Section: Discussionmentioning

confidence: 51%

“…Recombinant thrombomodulin is generally recommended in DIC associated with adult AML. This novel agent seems to mediate fewer hemorrhagic side‐effects than low‐molecular‐weight heparin and improves overall survival . Daily rTM from admission, however, failed to prevent severe epistaxis in the present young patient.…”

Section: Discussionmentioning

confidence: 67%

“…These laboratory data were consistent with a diagnosis of DIC, in accordance with the Japanese Ministry of Health and Welfare DIC scoring system (total score of 8 points, not including bleeding and platelet count affected by AML-related myelosuppression). 20 Recombinant thrombomodulin (rTM) and fresh frozen plasma were given daily for the near-undetectable low Fbg. After the diagnosis of AML, low-dose cytarabine (CA) was followed by induction chemotherapy consisting of etoposide (Etp), CA and mitoxantrone (ECM), together with the anti-DIC therapy.…”

Section: Patient Profilementioning

confidence: 99%

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Hemostatic function in hyperfibrinolytic disseminated intravascular coagulation

Ishihara

Nogami

Onishi

et al. 2019

Pediatrics International

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Background Global hemostatic mechanism(s) in patients with disseminated intravascular coagulation (DIC) are poorly understood. There are few diagnostic criteria of DIC based on overall or global hemostatic mechanisms. Methods We have assessed in detailed the dynamic global hemostatic changes using thrombin and plasmin generation assay (T/P‐GA), clot fibrinolytic waveform analysis (CFWA) and not‐activated rotational thromboelastometry (NATEM), in a young girl with DIC associated with acute myeloid leukemia (AML). The ratios of endogenous thrombin potential (T‐EP) and plasmin lag time (P‐LT) relative to normal plasma was sourced from pooled normal plasma from healthy volunteers on T/P‐GA. Results The inverse P‐LT ratio prior to tranexamic acid (TXA) treatment was greater than the T‐EP ratio (1.1–2.8 and 0.83–1.2, respectively). Significant reduction in inverse P‐LT ratio (0.084–1.3) was observed after TXA treatment. The interval from clotting to the initiation of fibrinolysis (fibrinolysis lag time: FLT) in CFWA was significantly shorter than the control at onset (74.2–91.6 s vs 109 s), indicating enhanced fibrinolysis. Data from an adult with acute promyelocytic leukemia‐associated DIC also supportively showed a high inverse P‐LT ratio (2.1) and shortened FLT (83.7 s). The clotting time in patient whole blood using NATEM‐mode during an episode of severe epistaxis markedly shortened beyond control, but returned to normal after the addition of an anti‐tissue factor (TF) monoclonal antibody. Conclusion The release of intravascular TF contributed to sustained activation of coagulation and subsequent fibrinolytic activity in this patient with AML‐associated DIC, and T/P‐GA could provide better quantitative data than conventional assays in these circumstances.

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Section: Methodssupporting

confidence: 63%

Section: Discussionmentioning

confidence: 51%

Section: Discussionmentioning

confidence: 67%

Section: Patient Profilementioning

confidence: 99%

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Hemostatic function in hyperfibrinolytic disseminated intravascular coagulation

Ishihara

Nogami

Onishi

et al. 2019

Pediatrics International

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“…In a previous single‐center before‐and‐after study, we demonstrated that rhTM administration could attenuate organ dysfunction, especially respiratory dysfunction, in patients with sepsis‐induced DIC . However, the efficacy of rhTM in severe sepsis or sepsis‐induced DIC remains a matter of dispute because of limited evidence that it improves clinical outcomes, and there are distinct discrepancies regarding levels of recommendation of rhTM administration among the guidelines for the diagnosis and treatment of DIC .…”

Section: Introductionmentioning

confidence: 99%

Recombinant human soluble thrombomodulin in severe sepsis: a systematic review and meta‐analysis

Yamakawa

Aihara

Ogura

et al. 2015

Journal of Thrombosis and Haemostasis

145

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severe sepsis: a systematic review and meta-analysis. J Thromb Haemost 2015; 13: 508-19.See also Levi M. Recombinant soluble thrombomodulin: coagulation takes another chance to reduce sepsis mortality. This issue, pp 505-7.Summary. Background: Although recombinant human soluble thrombomodulin (rhTM) is a widely used novel anticoagulant agent for disseminated intravascular coagulation (DIC) in Japan, its clinical efficacy in sepsisinduced DIC has not been demonstrated convincingly. Objective: To assess the benefits and harms of rhTM in sepsis-induced DIC patients. Methods: We conducted a systematic review and meta-analysis of rhTM therapy for sepsis-induced DIC for both randomized controlled trials (RCTs) and observational studies (retrospective case-control studies and/or prospective cohort studies) separately. All-cause mortality (28-30 days) as efficacy and serious bleeding complications as adverse effect were measured as primary outcomes. We assessed body of evidence quality at the outcome level by using the Grading of Evidence, Assessment, Development and Evaluation (GRADE) approach. Results: We analyzed 12 studies (838 patients/3 RCTs; 571 patients/9 observational studies). Pooled relative risk was 0.81 (95% CI, 0.62-1.06) in the RCTs, indicating non-significant reduction in mortality, and 0.59 (95% CI, 0.45-0.77) in the observational studies. Meta-regression analysis revealed a significant negative slope between effect size of rhTM therapy and baseline mortality rate in individual studies (P = 0.012), suggesting that probability of a beneficial effect with rhTM therapy increases with increasing baseline risk. Risk of serious bleeding complications was not significantly different between rhTM and control groups. We judged the quality of evidence as moderate for mortality and serious bleeding. Conclusions: The rhTM was associated with a trend in reduction of mortality at 28-30 days in sepsis-induced DIC patients. Further large rigorous trials are needed to confirm or refute these findings before implications for practice are clear.

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Hämostasestörungen – Diagnostik und Therapie

Dempfle¹,

Hoffmann

2015

Sepsis Und MODS

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Addition of recommendations for the use of recombinant human thrombomodulin to the “Expert consensus for the treatment of disseminated intravascular coagulation in Japan”

Cited by 35 publications

References 10 publications

Hemostatic function in hyperfibrinolytic disseminated intravascular coagulation

Hemostatic function in hyperfibrinolytic disseminated intravascular coagulation

Recombinant human soluble thrombomodulin in severe sepsis: a systematic review and meta‐analysis

Hämostasestörungen – Diagnostik und Therapie

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