EUCTR2011-002685-20-DK进行中（未招募）不适用
REPLACE (Randomized evaluation of fibrinogen versus placeboin complex cardiovascular surgery): a prospective, multinational,multicenter, randomized, double-blind, placebo-controlled, phaseIII study for the use of Fibrinogen Concentrate (Human) (FCH) incomplex cardiovascular surgery
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
- 152
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
- •Inclusion Criteria:
- •At Screening
- •· Undergoing elective open surgical procedures on any part of the aorta requiring CPB, with or without other cardiac surgical procedures (e.g. valve replacement or repair, coronary artery bypass grafting, etc.).
- •· 18 years of age or older.
- •· Written informed consent for study participation obtained before undergoing any study specific procedures. Intraoperative (at the 1st 5-minute bleeding mass)
- •· A 5-minute bleeding mass of 60 to 250 g following discontinuation of CPB, administration of protamine, and establishment of surgical hemostasis.
- •· Minimum core body temperature 35°C, measured according to local practice.
- •· Activated clotting time ±25% of baseline levels.
- •· Blood pH >7.3.
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 76
排除标准
- •Exclusion Criteria:
- •At Screening and/or baseline
- •· Undergoing emergency aortic repair surgery.
- •· Reoperative aortic surgery at the same anatomic site as the original procedure (including resternotomy).
- •· Any operation for infection.
- •· Proof or suspicion of a congenital or acquired coagulation disorder (e.g. Von Willebrand’s disease, hemophilia or severe liver disease) or a prothrombotic disorder (e.g. protein C or S deficiency).
- •· Myocardial infarction (MI), acute coronary syndrome or stroke in the 2 months preceding study surgery.
- •· Symptomatic carotid or vertebral artery disease.
- •· Planned concomitant peripheral vascular procedure (e.g. carotid endarterectomy).
- •· Low molecular weight or unfractionated heparin in the 24 hours preceding study surgery.
- •· Clopidogrel administration within 5 days preceding study surgery or prasugrel administration within 7 days preceding study surgery or ticagrelor administration in the24 hours preceding study surgery.
- •· Factor Xa inhibitors within 2 days preceding study surgery.
- •· IIb/IIIa antagonist administration in the 24 hours preceding study surgery.
- •· Use of direct thrombin inhibitors: within 3 days preceding study surgery for dabigatran and within 24 hours preceding study surgery for all others.
- •· An international normalized ratio >1.3 immediately preceding the start of surgery.
- •· Multiple morbidities, including those that may be discovered during pre-operative evaluation, that result in an anticipated life expectancy of <6 months.
- •· Participation in another interventional clinical study (or use of another IMP) within 30 days before, or during, the study. Participation in an observational clinical study is permitted.
- •· Alcohol, drug, or medication abuse within 1 year before the study that would preclude participation and compliance with study requirements.
- •· Use of concomitant therapy not permitted during the study.
- •· Suspected inability to understand or unwillingness to comply with study procedures.
- •· Mental condition rendering the subject (or the subject’s legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study.
- •· Known or suspected hypersensitivity to the IMP, or to any excipients of the IMP.
- •· Known or suspected antibodies to the IMP, or to any excipients of the IMP.
- •· Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
- •· Employee at the study site, or spouse/partner or relative of the investigator or subinvestigators.
- •· Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
- •· Pregnancy or nursing mother.
- •· Known, active infection with hepatitis A, B, or C virus or human immunodeficiency virus-1. Intraoperative (at the 1st 5-minute bleeding mass)
- •· Use of any systemic hemostatic therapy (such as FFP, platelets, prothrombin complex concentrates) from the beginning of surgery until IMP administration.
- •· Any situation that the surgical team feels may cause participation in the study threatens the safety of the subject.
研究者
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