Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- Composite of all-cause mortality or type 1-4 bleeding
研究概览
简要总结
Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking.
The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of all-cause mortality or clinically relevant bleeding within 30 days after transcatheter aortic valve implantation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Aged > 18 years
- •Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
- •Provided written informed consent
排除标准
- •Documented protamine allergy or anaphylaxis
- •Recent PCI (< 3 months before TAVI)
- •Planned arterial access via surgical cut-down
研究组 & 干预措施
Routine protamine administration
Routine protamine administration in a ratio of 1 IE per 1 IE of unfractionated heparin.
干预措施: Protamine sulfate (Drug)
Selective protamine administration
Selective protamine administration, in case of (threatening) bleeding.
干预措施: Protamine sulfate (Drug)
结局指标
主要结局
Composite of all-cause mortality or type 1-4 bleeding
时间窗: 30 days after TAVI
According to the VARC-3 criteria
次要结局
- Major vascular complications(30 days after TAVI)
- Cardiovascular mortality(30 days after TAVI)
- All-cause mortality(30 days after TAVI)
- All bleeding(30 days after TAVI)
- All bleeding(30 days after TAVI)
- Major, life-threatening or fatal bleeding(30 days after TAVI)
- Major vascular complications(30 days after TAVI)
- Cardiovascular mortality(30 days after TAVI)
- All-cause mortality(30 days after TAVI)
研究者
Jurriën M. ten Berg, MD, PhD
MD, PhD
St. Antonius Hospital