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Harmonized guidance for disseminated intravascular coagulation from the International Society on Thrombosis and Haemostasis and the current status of anticoagulant therapy in Japan: a rebuttal

2013; Elsevier BV; Volume: 11; Issue: 11 Linguagem: Inglês

10.1111/jth.12366

1538-7933

Hideo Wada, Jecko Thachil, Marcello Di Nisio, Shinichiro Kurosawa, Satoshi Gando, Cheng‐Hock Toh,

Clinical practice guidelines implementation

Journal of Thrombosis and HaemostasisVolume 11, Issue 11 p. 2078-2079 Letter to the EditorFree Access Harmonized guidance for disseminated intravascular coagulation from the International Society on Thrombosis and Haemostasis and the current status of anticoagulant therapy in Japan: a rebuttal H. Wada, Corresponding Author H. Wada Department of Molecular and Laboratory Medicine, Mie University School of Medicine, Mie, Japan Correspondence: Hideo Wada, Department of Molecular and Laboratory Medicine, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507, Japan. Tel.: +81 59 232 1111; fax: +81 59 231 5204. E-mail: wadahide@clin.medic.mie-u.ac.jpSearch for more papers by this authorJ. Thachil, J. Thachil Department of Haematology, Manchester Royal Infirmary, Manchester, UKSearch for more papers by this authorM. Di Nisio, M. Di Nisio Department of Medical, Oral and Biotechnological Sciences University “G.D'Annunzio” of Chieti-Pescara, Chieti, Italy Department of Vascular Medicine, Academic Medical Center, Amsterdam, The NetherlandsSearch for more papers by this authorS. Kurosawa, S. Kurosawa Department of Pathology and Laboratory Medicine, Boston University School of Medicine, Boston, MA, USASearch for more papers by this authorS. Gando, S. Gando Division of Acute and Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Hokkaido University Graduate School of Medicine, Sapporo, JapanSearch for more papers by this authorC.-H. Toh, C.-H. Toh The Roald Dahl Haemostasis & Thrombosis Centre, Royal Liverpool University Hospital, Liverpool, UK Institute of Infection and Global Health, University of Liverpool, Liverpool, UKSearch for more papers by this author on behalf of the Scientific and Standardization Committee on DIC of the International Society on Thrombosis and Haemostasis, the Scientific and Standardization Committee on DIC of the International Society on Thrombosis and HaemostasisSearch for more papers by this author H. Wada, Corresponding Author H. Wada Department of Molecular and Laboratory Medicine, Mie University School of Medicine, Mie, Japan Correspondence: Hideo Wada, Department of Molecular and Laboratory Medicine, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507, Japan. Tel.: +81 59 232 1111; fax: +81 59 231 5204. E-mail: wadahide@clin.medic.mie-u.ac.jpSearch for more papers by this authorJ. Thachil, J. Thachil Department of Haematology, Manchester Royal Infirmary, Manchester, UKSearch for more papers by this authorM. Di Nisio, M. Di Nisio Department of Medical, Oral and Biotechnological Sciences University “G.D'Annunzio” of Chieti-Pescara, Chieti, Italy Department of Vascular Medicine, Academic Medical Center, Amsterdam, The NetherlandsSearch for more papers by this authorS. Kurosawa, S. Kurosawa Department of Pathology and Laboratory Medicine, Boston University School of Medicine, Boston, MA, USASearch for more papers by this authorS. Gando, S. Gando Division of Acute and Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Hokkaido University Graduate School of Medicine, Sapporo, JapanSearch for more papers by this authorC.-H. Toh, C.-H. Toh The Roald Dahl Haemostasis & Thrombosis Centre, Royal Liverpool University Hospital, Liverpool, UK Institute of Infection and Global Health, University of Liverpool, Liverpool, UKSearch for more papers by this author on behalf of the Scientific and Standardization Committee on DIC of the International Society on Thrombosis and Haemostasis, the Scientific and Standardization Committee on DIC of the International Society on Thrombosis and HaemostasisSearch for more papers by this author First published: 08 August 2013 https://doi.org/10.1111/jth.12366Citations: 19 See also Wada H, Thachil J, Di Nisio, M, Mathew P, Kurosawa S, Gando S, Kim HK, Nielsen JD, Dempfle C-E, Levi M, Toh C-H. Guidance for diagnosis and treatment of disseminated intravascular coagulation from harmonization of the recommendations from three guidelines. J Thromb Haemost 2013; 11: 761–7 and Iba T. Harmonized guidance for disseminated intravascular coagulation from the International Society on Thrombosis and Haemostasis and the current status of anticoagulant therapy in Japan. This issue, pp 2076–8. AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat We are happy to respond to the important comments from Dr. Iba 1 and have an opportunity to explain further how to apply our guidance for the management of disseminated intravascular coagulation (DIC). The ISTH/Scientific and Standardization Committee (SSC) guidance 2 has been developed for physicians worldwide, while the three guidelines established by the British Committee for Standards in Haematology (BCSH) 3, the Japanese Society of Thrombosis and Hemostaisis (JSTH) 4, and the Italian Society for Thrombosis and Hemostaisis (SISET) 5 were made specifically for the physicians in each country, which have different environments and regulations. However, the three guidelines share many common recommendations, such as those regarding the treatment of underlying diseases and transfusion of fresh frozen plasma or platelet concentrate. Nevertheless, the three guidelines differ in their recommendations regarding the transfusion of fibrinogen concentrate and antifibrinolysis treatment, and we recommend that readers follow the ISTH guidance, because these treatments can be performed in most countries and the evidence levels for these treatments are relatively high. Also different among these three guidelines are the recommendations regarding the administration of anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), heparin sulfate (HS), gabexate mesilate (GM), nafamostat mesilate (NM), antithrombin (AT), activated protein C (APC), and recombinant human thrombomodulin (rhTM), and in this case, we recommend that physicians follow the local guidelines. Because most physicians outside Japan are unable to use GM, NM, APC, or rhTM, the ISTH guidance does not recommend these drugs. The evidence for UFH and LMWH is limited for DIC but it is abundant for venous thromboembolism. Almost all of the randomized controlled trials (RCTs) of AT 6, rhAPC 7, and rhTM 8 were for patients with severe sepsis, and none of the RCTs were able to fully improve the mortality of patients with severe sepsis with the exception of some subgroup analyses. In Japan, almost all of previous clinical trials for DIC were not RCTs and the recent RCTs of plasma-derived APC 9 and rhTM 10 for DIC used UFH as control treatment. As there is no evidence of a benefit of UFH for DIC, it is currently not recommend. If evidence can be generated demonstrating that UFH is superior to placebo in the treatment of DIC, UFH, APC, and rhTM can be recommended. However physicians may not be able to administer a placebo to the patients with DIC in Japan due to ethical concerns. However, we should perform a superiority trial of new drugs in comparison to UFH. As UFH may possibly be effective for DIC, it will be likely hard to prove that a drug is statistically superior to UFH in the treatment of DIC. Many RCTs for AT, APC, and rhTM showed a potential to improve the mortality of the patients with DIC, so AT, rhTM, and/or APC may be considered for DIC patients based on ISTH guidance. However, we acknowledged in the guidance the low quality of the evidence and, accordingly, we provided a low-degree recommendation and call for further evidence. We have based the guidelines on the principle that the improvement of mortality is the most important goal for severe sepsis. However, in the future, we would like to evaluate not only the improvement in mortality but also the resolution rate from DIC in DIC trials. Disclosure of Conflict of Interest The authors state that they have no conflicts of interest. References 1Iba T, Harmonized guidance for DIC from ISTH the current status of anticoagulant therapy in Japan. J Thromb Haemost 11: 2076– 8. Google Scholar 2Wada H, Thachil J, Di Nisio M, Mathew P, Kurosawa S, Gando S, Kim HK, Nielsen JD, Dempfle CE, Levi M, Toh CH, The Scientific Standardization Committee on DIC of the International Society on Thrombosis Haemostasis: Guidance for diagnosis and treatment of disseminated intravascular coagulation from harmonization of the recommendations from three guidelines. J Thromb Haemost 2013; 11: 761– 7. Wiley Online LibraryCASGoogle Scholar 3Levi M, Toh CH, Thachil J, Watson HG. Guidelines for the diagnosis and management of disseminated intravascular coagulation. British Committee for Standards in Haematology. Br J Haematol 2009; 145: 24– 33. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar 4Wada H, Asakura H, Okamoto K, Iba T, Uchiyama T, Kawasugi K, Koga S, Mayumi T, Koike K, Gando S, Kushimoto S, Seki Y, Madoiwa S, Maruyama I, Yoshioka A, Japanese Society of Thrombosis Hemostasis/DIC subcommittee: Expert consensus for the treatment of disseminated intravascular coagulation in Japan. Thromb Res 2010; 125: 6– 11. CrossrefCASPubMedWeb of Science®Google Scholar 5Di Nisio M, Baudo F, Cosmi B, D'Angelo A, De Gasperi A, Malato A, Schiavoni M, Squizzato A, on behalf of the Italian Society for Thrombosis and Haemostasis: Diagnosis and treatment of disseminated intravascular coagulation: Guidelines of the Italian Society for Haemostasis and Thrombosis (SISET). Thromb Res 2012; 129: e177– 84. CrossrefCASPubMedWeb of Science®Google Scholar 6Warren BL, Eid A, Singer P, Pillay SS, Carl P, Novak I, Chalupa P, Atherstone A, Penzes I, Kubler A, Knaub S, Keinecke HO, Heinrichs H, Schindel F, Juers M, Bone RC, Opal SM. Caring for the critically ill patient. High-dose antithrombin III in severe sepsis: a randomized controlled trial. JAMA 2001; 286: 1869– 78. CrossrefCASPubMedWeb of Science®Google Scholar 7Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gårdlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD, PROWESS-SHOCK Study Group: Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med 2012; 366: 055– 64. CrossrefCASWeb of Science®Google Scholar 8Kaul I, Tsuruta K, Gorelick K, Osawa Y, Hoppensteadt D, Fareed J, Vincent J-L: A Randomized, Double-Blind, Placebo- Controlled, Phase-2B Study to Evaluate the Safety and Efficacy of Recombinant Human Soluble Thrombomodulin, ART-123, in Patients with Sepsis and Suspected Disseminated Intravascular Coagulation. 54th Annual Meeting and Exposition of the American Society of Hematology, held at the Georgia World Congress Center, Atlanta, GA Google Scholar 9Aoki N, Matsuda T, Saito H, Takatsuki K, Okajima K, Takahashi H, Takamatsu J, Asakura H, Ogawa N; CTC-111-IM Clinical Research Group. A comparative double-blind randomized trial of activated protein C and unfractionated heparin in the treatment of disseminated intravascular coagulation. Int J Hematol 2002; 75: 540– 7. CrossrefCASPubMedWeb of Science®Google Scholar 10Saito H, Maruyama I, Shimazaki S, Yamamoto Y, Aikawa N, Ohno R, Hirayama A, Matsuda T, Asakura H, Nakashima M, Aoki N. Efficacy and safety of recombinant human soluble thrombomodulin (ART-123) in disseminated intravascular coagulation: results of a phase III, randomized, double-blind clinical trial. J Thromb Haemost 2007; 5: 31– 41. Wiley Online LibraryCASPubMedWeb of Science®Google Scholar Citing Literature Volume11, Issue11November 2013Pages 2078-2079 ReferencesRelatedInformation