EUCTR2017-001163-20-GB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
相关药物
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
- 200
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 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*:
- •Intra-operative prediction of clinically relevant bleeding of > 2 L, requiring hemostatic treatment during surgery
- •*Approximately 60 minutes after the start of cytoreductive PMP 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
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
相似试验
进行中（未招募）
1 期
Clinical study investigating efficacy and safety of BT524 in intra-operative use in patients undergoing major spine surgeryElective spine surgery with expected major blood lossMedDRA version: 20.0Level: PTClassification code 10051125Term: HypofibrinogenaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2017-001163-20-BEBiotest AG200
进行中（未招募）
1 期
Clinical study investigating efficacy and safety of BT524 in intra-operative use in patients undergoing major spinal or abdominal surgeryEUCTR2017-001163-20-DEBiotest AG220
进行中（未招募）
1 期
Clinical study investigating efficacy and safety of BT524 in intra-operative use in patients undergoing major spine surgeryEUCTR2017-001163-20-ESBiotest AG200
进行中（未招募）
1 期
Clinical study investigating efficacy and safety of BT524 in intra-operative use in patients undergoing major spinal or abdominal surgeryElective spinal or abdominal surgery with expected major blood lossMedDRA version: 20.0Level: PTClassification code 10051125Term: HypofibrinogenaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2017-001163-20-CZBiotest AG220
尚未招募
不适用
A Multi-center, Randomized, Active-controlled, Parallel Design, Low-Intervention Clinical Trial; Pitavastatin Comparing with Atorvastatin in Patients with Pre-Diabetes Mellitus and Hypercholesterolemia for evaluate the New Onset Diabetes Mellitus (PIANO-DM study)Endocrine, nutritional and metabolic diseaseKCT0005394The Catholic University of Korea, Bucheon St. Mary's Hospital706