A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment With Two Different Doses of Recombinant Factor XIII Following Cardiopulmonary Bypass Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 479
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
研究概览
简要总结
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve
排除标准
- •Known intolerance to protamine
- •Known or suspected allergy to the used antifibrinolytic agent
- •Refusal to receive blood or blood product
- •Planned surgery including the aortic arch and/or descending aorta
- •Planned surgery including any implantable ventricular assist device
- •Adult congenital heart diseases
- •Two or more previous cardiac surgery procedures
- •Any known autoimmune diseases: Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic: Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary antiphospholipid syndrome
- •Weight above 140 kg
研究组 & 干预措施
FXIII35IU/Kg
Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
干预措施: catridecacog (Drug)
Placebo
Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
干预措施: placebo (Drug)
FXIII17.5IU/Kg
Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
干预措施: catridecacog (Drug)
结局指标
主要结局
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First
时间窗: measured ongoing from dosing until day 7 or discharge, whichever came first
Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.
次要结局
- Percentage of Subjects With Thromboembolic Events(measured from screening until 5-7 weeks post Trial Drug Administration)
- Percentage of Subjects With rFXIII Antibody Reaction(measured from screening until 5-7 weeks post Trial Drug Administration)
- Percentage of Subjects With Critical Adverse Events(measured from screening until 5-7 weeks post Trial Drug Administration)
- Percentage of Subjects With Serious Adverse Events(measured from screening until 5-7 weeks post Trial Drug Administration)