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
- Conditions
- Acute bleeding while undergoing aortic replacement surgeryMedDRA version: 14.1Level: LLTClassification code 10049052Term: Aortic surgery NOSSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-002685-20-IT
- Lead Sponsor
- CSL BEHRING GMBH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 152
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: 0
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method