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.

Octapharma Pharmazeutika Produktionsges.m.b.H0 个研究点目标入组 370 人开始时间: 2017年3月2日最近更新: 2022年5月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Octapharma Pharmazeutika Produktionsges.m.b.H
入组人数: 370

研究概览入排标准研究者记录与标识符相似试验

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 in normal coagulation state) is required as part of routine clinical care within 24 hours of the start of investigational medicinal product;
•VKA withdrawal and 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 (e.g. Fontaine IV) or disseminated intravascular coagulation within 3 months of enrollment. (Note: ongoing thrombosis in-situ or severe unilateral peripheral arterial disease (PAD) undergoing surgical intervention is not an exclusion criterion).
•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 more than 5000 units of systemic unfractionated heparin (UFH), any dose of low-molecular-weight heparin (LMWH) or any dose of non-VKA anticoagulant (i.e. direct oral anticoagulant) within 24 hours prior to enrollment into the study or have potential need to receive these medications in mentioned doses 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 receiving P2Y12 platelet inhibitors (e.g. Clopidogrel, Prasugrel, Ticagrelor)
•11. Patients with a known history of hypersensitivity to plasma-derived products.
•12. Patients requiring urgent surgical procedures where according to the surgeon's clinical judgment an accurate estimate of expected blood loss and transfusion requirements is not possible, e.g.:
•a. Surgeries requiring massive transfusion protocols (e.g., major polytrauma,
•major injuries, organ transplant surgeries),
•b. Patients with acute major bleeding (e.g., gastrointestinal bleeds, obstetric
•haemorrhage),
•c. Surgeries with unpredictable intraoperative blood loss (e.g., ruptured aneurysm,
•primary surgery for intracranial hemorrhage (ICH)).
•13. Pregnant or nursing women.
•14. Patients participating in another interventional clinical study currently or during the past 30 day prior to enrollment into this study.
•15. Patients previously enrolled in this study.

研究者

发起方

Octapharma Pharmazeutika Produktionsges.m.b.H

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