Patients Immediate Mobilization After Coronary Angiography and Percutaneous Coronary Intervention. Is it SAfe to MObilize Patients Very eARly After Cardiac Catheterisation?
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Hematoma> 5 cm
研究概览
简要总结
The purpose of this study is to investigate the frequency of bleeding and haematomas in patients undergoing coronary angiography or percutaneous coronary intervention via femoral artery and mobilized immediately after the procedure, compared to those mobilized after two hours (following the standard regimen). At the same time the investigators will investigate whether it reduces the discomfort being mobilized immediately after the procedure.
详细描述
The frequency of hematoma, bleeding or pseudoaneurysm at the access site in the groin is 7-15% with regimens that involve 0-2 hours of bed rest, somewhat more frequent after Percutaneous coronary intervention (PCI) than coronary angiography (CAG). There seems to be no reduction in the complications of the CAG or PCI by maintaining the bed rest for more than 2 hours after the procedure. Angio-Seal seems most effective of current closure devices. There is less discomfort associated with early compared with late mobilization. Protamine reverse heparin's effect without the side effects of that regime.
There lacks a larger randomized study of the safety of mobilizing patients immediately after CAG and after PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •CAG or PCI performed via the femoral artery
- •No hematoma in the groin (> 5 cm in diameter)
- •Heparin reversed with protamine after PCI
排除标准
- •Oozing, bleeding or hematoma
- •Treatment with Integrilin, ReoPro, or Marevan
- •Heparin can not be reversed
- •The patient does not want to participate
- •Systolic blood pressure > 180 mm Hg after the procedure
- •BMI> 35 (can be modified if the groin can be assessed in an upright position)
- •Demented, unconscious patients who do not understand the information for participants.
结局指标
主要结局
Hematoma> 5 cm
时间窗: participants will be followed for the duration of hospital stay, an expected average of 24 hours
occurred after the end of the procedure, including retroperitoneal hematoma, bleeding requiring transfusion or pseudoaneurysm that require vascular surgical intervention. Assessed after 30 minutes, after two hours and before discharge
次要结局
- The presence of hematoma> 10 cm in diameter(participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- The presence of hematoma 2-5 cm in diameter(participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Oozing or bleeding from the puncture site(participants will be followed for the duration of hospital stay, an expected average of 24 hours)
- Comfort rating (NRS scale)(Two hours after the procedure)
研究者
Marianne Wetendorff Noergaard
Clinical Nurse Specialist
Rigshospitalet, Denmark