2023-504205-36-00招募中4 期
Routine versus selective protamine administration to reduce bleeding complications after transcatheter aortic valve implantation
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 6
- 主要终点
- The composite of cardiovascular mortality or clinically relevant bleeding (VARC-3 type 1-4) within 30 days after TAVI procedure.
研究概览
简要总结
To determine if routine protamine administration, compared with selective protamine administration, reduces the risk of the composite endpoint of all-cause death or clinically relevant bleeding within 30 days after TAVI.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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
结局指标
主要结局
The composite of cardiovascular mortality or clinically relevant bleeding (VARC-3 type 1-4) within 30 days after TAVI procedure.
The composite of cardiovascular mortality or clinically relevant bleeding (VARC-3 type 1-4) within 30 days after TAVI procedure.
次要结局
- All bleeding (VARC-3 type 1-4)
- Major, life-threatening or fatal bleeding (VARC-3 type 2-4)
- Major vascular complications (VARC-3)
- Cardiovascular mortality (VARC-3)
- All-cause mortality
研究者
Dirk-Jan van Ginkel
Scientific
St Antonius Hospital
研究点 (6)
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