Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Time to Ambulation
研究概览
简要总结
The objective of this study is to evaluate the safety, efficacy and efficiency of rapid anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT) monitoring in patients undergoing catheter based ablation of atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial fibrillation or atrial flutter (left atrial).
- •Age ≥ 18 year
- •Patients who are mentally and linguistically able to understand the aim of the trial, comply with the trial protocol, verbally acknowledge the risks, benefits, and alternatives in this trial.
排除标准
- •Previous intolerance or allergy to heparin products.
- •Current or prior administration of protamine products
- •History of femoral access site complications including hematoma, AV fistula, pseudoaneurysm, aneurysm.
- •Known lower extremity venous thrombosis.
- •Coagulopathy or blood dyscrasias.
- •Active malignancy.
- •Thrombocytosis (platelet count >600k/ul) or thrombocytopenia (platelet count <100k/ul)
- •Planned use of vascular closure device
研究组 & 干预措施
Protamine
Patients in the active comparator arm will receive protamine sulfate for rapid reversal of heparin prior to sheath removal. They will first receive a small test dose with close hemodynamic monitoring followed by therapeutic dose if no reaction occurs.ACT levels will then be monitored with a goal ACT of <200s or return to preprocedural baseline prior to removal of vascular sheaths.
干预措施: Protamine Sulfate (Drug)
结局指标
主要结局
Time to Ambulation
时间窗: 0 to 24 hours
Total length of time from procedural termination to patient ambulation
次要结局
- Count of Participants Who Experienced Vascular Access Site Complications(checked at 30 and 90 days)
研究者
Hakan Oral
Director, Cardiac Arrhythmia Service
University of Michigan