CTIS2023-507560-39-00进行中（未招募）1 期
Phase 3, double-blind, placebo-controlled, multicentre study on the efficacy and safety of human plasma derived antithrombin (Atenativ) in heparin-resistant patients scheduled to undergo cardiac surgery necessitating cardiopulmonary bypass - ATN-108
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Planned cardiac surgery with CPB, Heparin-resistant patients: pre-CPB Hemochron ACT less than 480 seconds in the measurement performed between 2 and 5 minutes following intravenous administration of 500 U/kg BW UFH, Patients =18 and =85 years of age, Freely given written or electronic informed consent, In female patients of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile), a pre-existing negative pregnancy test within 14 days prior to surgery
排除标准
- •Receiving or have received one or more of the following medications within the specified time frames prior to the start of the surgery: a) warfarin (within 3 days) b) direct oral anticoagulants (within 2 days) c) ticlopidine (within 14 days) d) prasugrel (within 7 days) e) clopidogrel (within 5 days) f) ticagrelor (within 5 days) g) glycoprotein IIb/IIIa antagonist (within 1 day), Pre-existing coagulopathy, a history of bleeding problems or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder), Renal insufficiency, defined as serum creatinine level >1.5 mg/dL, Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan and caprylic acid, History of anaphylactic reaction(s) to blood or blood components, Refusal to receive transfusion of blood or blood-derived products, Current participation in another interventional clinical trial with an investigational medicinal product (IMP) or previous participation in the current trial, Treatment with any IMP within 30 days prior to screening visit
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