REPLACE (Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery): a prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, phase III study for the use of Fibrinogen Concentrate (Human) (FCH) in complex cardiovascular surgery

CSL Behring GmbH0 个研究点目标入组 152 人开始时间: 2011年9月6日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: CSL Behring GmbH
入组人数: 152

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

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 such as replacement of a previously placed aortic graft. Resternotomy and rethoracotomy are permitted.
•· 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

研究者

发起方

CSL Behring GmbH

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