NCT05422170Unknown不适用
Heparin Influence on Anticoagulation and Perioperative Hemostasis During Transfemoral Transcatheter Aortic Valve Implantation
Deutsches Herzzentrum Muenchen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary endpoint
研究概览
简要总结
Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Severe aortic valve Stenosis
- •transfemoral TAVI as best therapy option
- •unfractioned heparin for periprocedural anticoagulation
排除标准
- •known hypersensitivity /allergy to unfractioned heparin or protamine
- •acute systemic infection
- •pre procedural started and ongoing intravenous therapy with unfractioned heparin
- •severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
- •refusal of the patient to participate
结局指标
主要结局
Primary endpoint
时间窗: Periprocedural
Variability of the ROTEM CT(INTEM) after partial heparin reversal
次要结局
未报告次要终点
研究者
研究点 (1)
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