"Salvage Use" of Recombinant Activated Factor VII After Inadequate Haemostatic Response to Conventional Therapy in Complex Cardiac Surgery - a Randomised Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Adequate haemostasis to enable chest closure after administration of trial medication without the need for further intervention to improve coagulation.
研究概览
简要总结
Aims and Hypotheses:
This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to conventional therapy in complex cardiac surgery.
Major bleeding is still of concern in complex cardiac surgery. It has been shown to be associated with poorer patient outcome and results in the consumption of resources (hospital costs, manpower and blood bank reserves). This study has the potential to provide evidence that rVIIa can reduce transfusion requirements and improve patient outcome in a problematic aspect of complicated cardiac surgery.
The objective is to conduct a multi-centre randomised placebo controlled study that has been designed to scientifically evaluate the treatment of post bypass coagulopathy in the association with complex cardiac surgery. The trial design is based on clinical practice that has evolved over 2 years at the Austin Hospital during which 38 patients have received open label administration of rVIIa. There is currently no published RCT in this area and there is no TGA approval for the use of rVIIa for this indication.
详细描述
- 3 Methods
Synopsis of Study:
A multicentred randomised, double blind, placebo-controlled trial evaluating the efficacy and safety of activated recombinant factor VII (rVIIa) in complex cardiac surgery.
Study will be conducted at Austin Hospital, Alfred Hospital and Warringal Private Hospital.
The study will have two arms:
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with scheduled cardiac surgery undergoing the following procedures
- •Double valve replacements or repair.
- •Major thoracic aortic surgery including hypothermic circulatory arrest or descending aortic reconstruction.
- •Valve repair or replacement in the setting of endocarditis
- •Complex procedures requiring cardiopulmonary bypass duration anticipated to exceed 180 minutes in patients aged ³70 years
排除标准
- •Patient unable to give informed consent
- •Patient refusal
- •Allergy to rVIIa
- •Allergy to aprotinin or prior exposure within 6 months
- •Pre-existing congenital coagulopathy
- •Pre-existing hypercoagulable state
- •Patients in inclusion criteria whose actual bypass time does not exceed 180 minutes
- •Unresolved surgical bleeding
结局指标
主要结局
Adequate haemostasis to enable chest closure after administration of trial medication without the need for further intervention to improve coagulation.
次要结局
- Percentage of cases that haemostasis after first administration of coagulation factors alone
- Assessment of surgical field after administration of trial medication
- Time to closure of chest after administration of trial medication
- Transfusion requirements in post bypass period in theatre
- Transfusion requirements in ICU first 12 hours
- Mediastinal drainage in ICU first 12 hours
- Coagulation study results at various sample times
- Requirement for chest re-exploration
- Ventilation duration in ICU
- Duration of stay in ICU