NCT02155725已完成4 期
Study on the Efficacy and Safety of a Therapeutic Strategy of PPH Comparing Early Administration of Human Fibrinogen vs Placebo in Patients Treated With IV Prostaglandins Following Vaginal Delivery
Laboratoire français de Fractionnement et de Biotechnologies31 个研究点 分布在 2 个国家目标入组 448 人开始时间: 2014年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 448
- 试验地点
- 31
- 主要终点
- Failure Rate of PPH Management
研究概览
简要总结
The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.
详细描述
Randomised, double-blind,multicenter, placebo-controlled study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form
- •Vaginal delivery
- •PPH requiring IV administration of prostaglandins
- •At least one available result of Hb level during the third trimester of pregnancy
- •18-year-old female patients and older
- •Covered by healthcare insurance in accordance with local requirements
排除标准
- •Caesarean section
- •Haemostatic intervention (as ligation, embolization or hysterectomy) already decided at the time of inclusion
- •Known placenta praevia or accreta
- •Hb level < 10g/dl during the third trimester of pregnancy
- •History of venous or arterial thromboembolic event
- •Known inherited bleeding or thrombotic disorders
- •Treatment with low-molecular-weight heparin (LMWH) within 24 hours prior to the inclusion
- •Treatment with acetylsalicylic acid within 5 days prior to the inclusion
- •Treatment with vitamin K antagonists within 7 days prior to the inclusion
- •Administration of fibrinogen concentrate within 48 hours prior to the inclusion
- •Administration of FFP, platelets units or prohaemostatic drugs, tranexamic acid and rFVIIa or prothrombin complex concentrates (PCC) within 48 hours prior to the inclusion
- •Administration of RBCs within 3 months prior to the inclusion
- •Participation in another interventional clinical study within 30 days prior to the inclusion
- •Previous inclusion/enrolment in the present clinical study
- •Known history of hypersensitivity or other severe reaction to any component of Clottafact® or placebo
- •Minors, majors under guardianship, persons staying in health or social institutes and people deprived of their freedom
- •Known drug or alcohol abuse
- •Patients whose use of concomitant medication may interfere with the interpretation of data
- •Any other current significant medical condition that might interfere with treatment evaluation according to the investigator's judgement
- •Patients who are unlikely to survive through the treatment period and evaluation
- •Patients transferred from another service
研究组 & 干预措施
Human Fibrinogen concentrate
Experimental
2 vials (200ml) / 3g intravenous
干预措施: Human Fibrinogen concentrate (Drug)
Placebo
Placebo Comparator
2 vials (200ml)
干预措施: Placebo (Drug)
结局指标
主要结局
Failure Rate of PPH Management
时间窗: Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration
The primary efficacy variable is a binary (Failure versus Success) composite endpoint. Failure is defined when a patient: * loses at least 4 g/dL of Hb compared to the reference Hb level , AND/OR * requires the transfusion of at least 2 units of packed RBCs.
次要结局
- Patients With at Least Administration of 2 Units of RBCs(from H0 to Day 2)
- Patients With Loss of at Least 4 g/dL of Hb(From reference value to Day 2)
研究者
研究点 (31)
Loading locations...
相似试验
已完成
2 期
Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette SyndromeTourette SyndromeNCT03066193Yale University17
Unknown
4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIKMyopiaHyperopiaNCT02071576Technolas Perfect Vision GmbH42
Unknown
4 期
A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and PresbyopiaHyperopiaPresbyopiaMyopiaNCT02112968Technolas Perfect Vision GmbH97
Unknown
4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIKMyopiaHyperopiaPresbyopiaNCT01977807Technolas Perfect Vision GmbH100
尚未招募
4 期
The Possible Efficacy and Protective Effect of Empagliflozin in Rheumatoid Arthritis Patients Treated with MethotrexateRheumatoid Arthritis (RA)Methotrexate Induced NephrotoxicityMethotrexate Adverse ReactionNCT06641128Tanta University44