EUCTR2010-019250-41-HU进行中（未招募）不适用
AN INTERNATIONAL, MULTI-CENTRE, PROSPECTIVE, OPEN-LABEL, NON-RANDOMISED, UNCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROTHROMPLEX TOTAL IN ORAL ANTICOAGULANT REVERSAL IN PATIENTS WITH ACQUIRED PROTHROMBIN COMPLEX COAGULATION FACTORS (II, VII, IX, X) DEFICIENCY - Efficacy and safety of Prothromplex Total in Reversal of Oral Anticoagulation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject is at least 18 years of age at enrolment with acquired prothrombin complex coagulation factor (II, VII, IX, X) deficiency, due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, invasive procedure or acute bleeding episode
- •Subject has provided written informed consent
- •Subject has INR = 2.0 at screening
- •Subject must have been on stable doses of anticoagulant or has a known history of stable INR for at least 72 hours prior to screening
- •Subject is willing and able to comply with the requirements of the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has laboratory and/or clinical symptoms which are clearly indicative of disseminated intravascular coagulation (DIC)
- •Subject has been treated with whole blood, fresh frozen plasma (FFP), or platelets within 6 hours prior to study enrolment
- •Subject has a hypersensitivity to PCC constituents (including heparin-induced thrombocytopenia)
- •Subject has blood loss of = 5 units of blood
- •Subject has known congenital Protein C, Protein S, or Antithrombin deficiency, or hereditary bleeding disorder
- •Subject has a life expectancy of < 3 months
- •Subject has been on oral anticoagulant treatment for a period of < 4 weeks for the treatment of a thrombotic event such as deep vein thrombosis or pulmonary embolism
- •Subject has an acute ischaemic cardiovascular disorder
- •Subject has or is suspected to have sepsis
- •Subject with acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
- •Subject has renal failure undergoing dialysis
- •Subject has participated in another clinical study involving an IP or device within 30 days prior to study enrolment or is scheduled to participate in another clinical study involving an IP or device during the course of this study
研究者
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