Treatment effect of thrombomodulin-^|^alpha; on septic disseminated intravascular coagulation (DIC): a historical cohort study

大介, 工藤; 洋太郎, 篠澤; 聡, 山内; 智之, 遠藤; 武揚, 佐藤; 宗, 古川; 亮介, 野村; 成樹, 久志本

doi:10.3918/jsicm.19.359

Cited by 5 publications

(6 citation statements)

References 25 publications

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“…S2). The authors of eight of these studies were contac‐ted for further information about these changes. There was no difference between groups in the changes in FDP (mean difference, −11.7 μg mL −1 ; 95% CI, −32.9 to 9.5 μg mL −1 ; P = 0.28; I 2 = 32%).…”

Section: Resultsmentioning

confidence: 99%

“…Figure 1 shows the PRISMA flow chart of study selection in the systematic review. We identified 12 articles (three RCTs and nine observational studies) in our systematic review (pooled sample size, 1409 patients; 838 in RCTs and 571 in observational studies) [14,23,[25][26][27][28][29][30][31][32][33][34].…”

Section: Discussionmentioning

confidence: 99%

“…We wish to express our gratitude to Drs. Takahashi , Ohryorji , Yada , Kudo , Umegaki , Kato , Sawano , Yamato , and Sha , who provided additional data necessary for meta‐analytic calculations.…”

Section: Acknowledgementsmentioning

confidence: 99%

“…S3). The authors of these eight studies [26][27][28][29][30][31][32]34] were contacted for further information on platelet counts. There was a statistically significant increase in platelet count in the rhTM group compared with the control group (mean difference, 3.66 9 10 4 lL À1 ; 95% CI, 1.89-5.44 9 10 4 lL À1 ; P < 0.01; I 2 = 13%).…”

Section: Changes In Hemostatic Markersmentioning

confidence: 99%

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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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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Acknowledgementsmentioning

confidence: 99%

Section: Changes In Hemostatic Markersmentioning

confidence: 99%

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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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“…Kudo et al. reported that serum concentrations of HMGB1 decreased within a couple of days after rTM administration in patients with sepsis‐induced DIC . We have also experienced cases in which an increase in HMGB1 was seen despite a chronological decrease in IL‐6 in patients who survived with combination therapy of PMX and rTM for septic shock complicated by DIC .…”

Section: Discussionmentioning

confidence: 87%

Effective Combination Therapy of Polymyxin‐B Direct Hemoperfusion and Recombinant Thrombomodulin for Septic Shock Accompanied by Disseminated Intravascular Coagulation: A Historical Controlled Trial

et al. 2013

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Disseminated intravascular coagulation (DIC) and multiple organ failure often occur via the crosstalk between inflammation and coagulation, which is mediated by High Mobility Group Box 1 (HMGB1). In septic shock, Polymyxin-B direct hemoperfusion (PMX-DHP) ameliorates hemodynamics by endogenous cannabinoid adsorption and improves pulmonary oxygenation by indirect cytokine reduction through the adsorption of activated mononuclear cells. However, PMX-DHP has no direct effect on HMGB1 circulating in the plasma. In cases with DIC, recombinant thrombomodulin (rTM), an effective drug for DIC, exerts not only anticoagulation but also antiinflammatory properties via direct anti-HMGB1 activity. Therefore, a combination of PMX-DHP and rTM is expected to block the vicious cycle of a cytokine storm ending up with multiple organ failure in DIC. The aim of this study was to investigate the efficacy of combination therapy for septic shock associated with DIC. This study comprised 22 consecutive patients with sepsis-induced DIC who received PMX-DHP. The initial eight patients were treated without rTM (historical control group), and the following 14 patients were given rTM (rTM group). The baseline Sequential Organ Failure Assessment (SOFA) score or age was not different between both groups. Sixtyday survival rate in the rTM group was significantly higher than that in the control group (85.7% vs. 37.5%, P = 0.015). A combination of PMX-DHP and rTM may be effective in septic shock accompanied by DIC and is expected to improve survival rates.

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Efficacy and safety of recombinant human soluble thrombomodulin in patients with sepsis-induced disseminated intravascular coagulation - A meta-analysis

Kato

Hagihara

Asai

et al. 2023

Thrombosis Research

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Treatment effect of thrombomodulin-^|^alpha; on septic disseminated intravascular coagulation (DIC): a historical cohort study

Cited by 5 publications

References 25 publications

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

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

Effective Combination Therapy of Polymyxin‐B Direct Hemoperfusion and Recombinant Thrombomodulin for Septic Shock Accompanied by Disseminated Intravascular Coagulation: A Historical Controlled Trial

Efficacy and safety of recombinant human soluble thrombomodulin in patients with sepsis-induced disseminated intravascular coagulation - A meta-analysis

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