EUCTR2016-002649-41-RO进行中（未招募）1 期
A Phase III, randomized, double-blind, multicenter study to assess the efficacy and safety of OCTAPLEX, a four-factor prothrombin complex concentrate (4F-PCC), compared to the 4F-PCC Beriplex® P/N (Kcentra), for the reversal of vitamin K antagonist induced anticoagulation in patients needing urgent surgery with significant bleeding risk.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 370
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
- •1. Male or female patients at least 18 years of age.
- •2. Patients currently on oral anticoagulation treatment with VKA of coumadin or warfarin type.
- •3. Patients being admitted to the hospital or currently hospitalized where:
- •an urgent surgery carrying significant bleeding risk (=50 mL expected blood loss) is required as part of routine clinical care;
- •the use of oral or parenteral vitamin K alone to reverse anticoagulation is deemed too slow or inappropriate for reversal;
- •4. Patients with an INR of 2.0 or above at the time of decision to reverse the anticoagulation status.
- •5. Patients who have given written informed consent and who are able and willing to comply with the procedures laid out in the study 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 222
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 148
排除标准
- •1. Patients with a life expectancy of less than 48 hours per physician’s judgment (e.g., patients with a Glasgow Coma Scale equal to 3 or a head Abbreviated Injury Score of 6, patients requiring continuous inotropic or pressor support, and patients whose status is post cardiac arrest).
- •2. Patients for whom the planned surgery or procedure is commonly associated with a very low bleeding risk (e.g., catheter placement, gastroscopy).
- •3. Patients with a history of TEEs, myocardial infarction (MI), unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, TIA, severe peripheral vascular disease, or disseminated intravascular coagulation within 3 months of enrollment.
- •4. Patients with a known congenital bleeding disorder.
- •5. Patients with a known antiphospholipid antibody syndrome.
- •6. Patients with present or past specific factor inhibitor activity.
- •7. Patients with thrombocytopenia of <80,000/µL or history of heparin-induced thrombocytopenia.
- •8. Patients who have received heparin of any type or any non-VKA anticoagulant within 24 hours prior to enrollment into the study or with potential need to receive these medications before completion of hemostasis evaluation at the end of surgery.
- •9. Patients who have received PCCs, FFP or vitamin K within 72 hours prior to enrollment into the study.
- •10. Patients with a known history of hypersensitivity to plasma-derived products.
- •11. Patients with acute major bleeding or polytrauma.
- •12. Pregnant or nursing women.
- •13. Patients participating in another interventional clinical study currently or during the past 30 day prior to enrollment into this study.
- •14. Patients previously enrolled in this study.
研究者
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