CTIS2023-504511-32-00进行中（未招募）1 期
ATLANTIS Protamine - Antagonization of heparin with protamine sulfate to reduce all neurologic ischemic and hemorrhagic events after transcatheter aortic valve implantation for aortic stenosis: the ATLANTIS Protamine study. - APHP211046
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 940
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Men and women =18 years of age, •Any patient eligible for transfemoral TAVI, irrespective of the chronic antithrombotic treatment, •Written informed consent, •Registered at the French social healthcare
排除标准
- •Any major protamine sulfate exposure contraindications defined as a history of severe pulmonary hypertension, acute pulmonary edema or history of bronchospasm related to protamine sulfate administration, •Pregnancy and breast feeding women, •Contemporaneous enrolment in an interventional clinical trial, •Patient under guardianship or curatorship, •Known allergy to protamine sulfate, •Hypersensitivity to protamine sulfate including protamine contained as an excipient in NPH [Neutral Protamine Hagedorn] insulin, known protamine or protamine-heparine complex antibodies, •Non-femoral approach for the TAVI procedure, •Protamine sulfate exposure within 24h of randomization, •Fish allergy, •Mechanical valves, •For men: Sterile or Vasectomy, •Women of childbearing potential
研究者
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