EUCTR2004-000100-40-DK进行中（未招募）不适用
A multi-centre, randomised, double-blind, placebo-controlled, dose escalation trial on safety and efficacy of activated recombinant factor VII (rFVIIa/NovoSeven®) in the treatment of post-operative bleeding in patients following cardiac surgery requiring cardiopulmonary bypass
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
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
- •Informed consent obtained before any trial-related activities.
- •Age = 18 years.
- •Subject is scheduled to undergo cardiac surgery requiring cardiopulmonary bypass.
- •Post-operative bleeding into drains placed in the cardio-thoracic cavity, assessed over a minimum of a 30 minutes period following completion of the 30 minutes stabilization period, defined as at least one of the following criteria:
- •= 200ml/hr in any one hour or part thereof, or
- •= 2 ml/kg/hr for 2 consecutive hours
- •(part thereof is defined by any 30 minutes period following the 30 minutes stabilization period)
- •The subject does not require urgent re-operation at the time of meeting inclusion criterion No. 5, as per the investigator’s judgment. Please refer to Appendix D for a re-operation guideline.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or breast-feeding (if applicable).
- •First time coronary artery bypass grafting with none or only one antiplatelet medication within 5 days of surgery*, or with normal preoperative coagulation (normal coagulation defined by INR<1.2, APTT within normal local reference range, or platelets > 150,000 10 6/L. If one or more values are outside of these values, coagulation is abnormal).
- •*One antiplatelet medication can be replaced by low molecular weight heparin within 12 hours of start of surgery to comply with the above.
- •Cardiac or cardiopulmonary transplantation procedure.
- •Refusal to receive blood or blood products due to religious or any other reasons.
- •Any history of stroke and/or non-coronary thrombotic disorders (including DVT, PE).
- •Clinical signs consistent with non-coronary thrombotic disease.
- •Known congenital deficiency of Protein C, Protein S, Antithrombin and homozygous FV Lei-den.
- •Patient having an unacceptable thrombotic risk, as per the investigator judgment. This encompasses any patient with additional coagulation related condition who, based upon the investigator’s professional judgment, would be at undue risk of thrombosis.
- •Current surgery including any implantable ventricular assist device requiring CPB including ECMO (extracorporal membrane oxygenation).
- •Current surgery including the aortic arch and/or descending thoracic aorta.
- •Known congenital bleeding disorders.
- •Administration of Activated Prothrombin Complex Concentrate (FEIBA, AUTOPLEX) during current surgery and/or any time before Just before dose.
研究者
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