EUCTR2017-001163-20-CZ进行中（未招募）1 期
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 spinal or abdominal surgery (AdFIrst) - AdFIrst
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biotest AG
- 入组人数
- 220
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
- •At screening:
- •1.Written informed consent
- •2.Subjects scheduled for elective major spinal or cytoreductive pseudomyxoma peritonei (PMP)* 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*
- •5.Intra-operative trigger for treatment:
- •a. Subjects undergoing spinal surgery: Intra-operative clinically relevant bleeding of approximately 1L, requiring hemostatic treatment during surgery**
- •b. Subjects undergoing cytoreductive PMP*surgery : Intra-operative prediction of clinically relevant bleeding of > 2 L, requiring hemostatic treatment during surgery***
- •*Inclusion criterion no. 4 aims to ensure that only subjects without hereditary bleeding disorders are to be included in this study. Subjects with continuous 'aspirin intake', subjects under Direct Oral Anti-Coagulants (DOACs), or with a hepatic disease are at higher bleeding risk. Nevertheless, these subjects can be included at the discretion of the investigator.
- •**A clinically relevant bleeding, resulting in a high risk for the need of fibrinogen supplementation with BT524 or FFP during surgery. The amount of clinically relevant blood loss depends on the subject's clinical condition, e.g. underlying disease, significant comorbidities, low body weight, relevant change of a laboratory value.
- •***Only applicable for subjects in the UK
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Pregnancy or unreliable contraceptive measures or breast feeding (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
研究者
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