A randomized, active-controlled, multicenter, phase III study investigating efficacy and safety of intra-operative use of BT524 (human fibrinogen concentrate) in subjects undergoing major spine surgery (AdFIrst) - AdFIrst

Biotest AG0 个研究点目标入组 200 人开始时间: 2017年7月26日最近更新: 2018年10月15日

适应症

试验速览

暂无简介。

•At screening:
•1.Written informed consent
•2.Subjects scheduled for elective major spine surgery with expected major blood loss
•3.Male or female, aged = 18 years
•4.No increased bleeding risk as assessed by standard coagulation tests and medical history
•Intra-operative:
•5.Intra-operative bleeding > 1,000 mL (total blood loss), resulting in a high risk for the need of FFP transfusion during surgery.
•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 160
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1.Pregnancy or unreliable contraceptive measures or lactation period (women only)
•2.Hypersensitivity to proteins of human origin or known hypersensitivity reactions to components of the Investigational Medicinal Products (IMP)
•3.Participation in another clinical study within 30 days before entering the study or during the study and/or previous participation in this study
•4.Treatment with any fibrinogen concentrate and/or fibrinogen-containing product within 30 days prior to infusion of IMP
•5.Employee or direct relative of an employee of the Contract Research Organization (CRO), the study site, or Biotest
•6.Inability or lacking motivation to participate in the study
•7.Medical condition, laboratory finding (e.g. clinically relevant biochemical or hematological findings outside the normal range), or physical exam finding that in the opinion of the investigator precludes participation
•8.Presence or history of venous/arterial thrombosis or TEE in the preceding 6 months

发起方