Observation and Prediction of Complications After Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Incidence of bleeding complications
研究概览
简要总结
Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding complications are often seen. To avoid/reduce bleeding complications digital compression is applied in the area of puncture during approximately 20 minutes and the patient is in the investigators' department observed in bed for 2 hours. The investigators apply pressure over the puncture site using a sand bag in the first hour. The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours (standard observation). In the present study the patients are randomized between standard observation and an alternative observation, where the patients are allowed to lift their head, arms and legs during the 2 hours, otherwise as standard observation.
The study has three aims:
- To establish the incidence of bleeding complications:
- Frequency of hematoma (> 5 cm)
- Frequency of pseudoaneurysms
- Frequency of bleeding demanding surgery
- Frequency of bleeding demanding transfusion
- Establish a model to predict in wich patient to expect a bleeding complication.
- Assess if the alternative observation is associated with more bleeding complications compared to standard observation.
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
- None
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
- •Coronary angiography by the femoral access, where the arterial lumen is reached.
- •Only attempted puncture at one side.
- •Age >= 18 years.
排除标准
- •Conditions that makes observation in the department impossible.
- •Dementia or other reasons to expect lack of compliance.
- •Previous participation in the project.
- •Implanted vascular prothesis at puncture site.
结局指标
主要结局
Incidence of bleeding complications
时间窗: 4 days
Model to predict bleeding complications
时间窗: 4 days
Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications
时间窗: 4 days
次要结局
未报告次要终点
