Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients
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DOI：
10.1111/j.1538-7836.2005.01204.x
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发表时间：
2005-04-01
影响因子：
10.4
通讯作者：
Kearon, C
中科院分区：
文献类型：
--
作者：
Schulman, S;Kearon, C
在已发表的临床研究中使用了各种大出血定义，这种多样性增加了比较试验间数据和进行荟萃分析的难度。在迈向出血并发症统一定义的第一步中，国际血栓和止血学会抗凝控制小组委员会讨论了非手术患者大出血的定义。根据该讨论，制定了一个定义，该定义应适用于所有干扰止血的药物的研究，包括抗凝剂、血小板功能抑制剂和纤溶药物。该定义和随后的案文已由小组委员会共同主席审查和批准，修订版在此公布。其目的也是寻求监管机构对这一定义的批准。
A variety of definitions of major bleeding have been used in published clinical studies, and this diversity adds to the difficulty in comparing data between trials and in performing meta-analyses. in the first step towards unified definitions of bleeding complications, the definition of major bleeding in nonsurgical patients was discussed at the Control of Anticoagulation Subcommittee of the International Society on Thrombosis and Haemostasis. Arising from that discussion, a definition was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs. The definition and the text that follows have been reviewed and approved by the cochairs of the subcommittee and the revised version is published here. The intention is to also seek approval of this definition from the regulatory authorities.