Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Correlation between ACT (second) realized in operative room and Anti Xa activity (UI/ml) results provide by the lab.
研究概览
简要总结
Activated clotting time (ACT) is currently recommended to monitor high concentrations heparin anticoagulation. ACT-LR was specifically designed to measure the activity of low dose of heparin used during endovascular surgery. The correlation between ACT-LR and Anti Xa activity which is considered as the gold standard seems to be debated.
Few studies in literature had shown controversial results. These studies were conducted in patients who underwent open as endovascular surgery. However, the ACT monitoring is not recommended in open surgery. In addition, heparin administration protocols are not described and specific to each centre.
In this study investigators want to study the correlation between LR-ACT and anti Xa after introducing a heparin protocol during complex endovascular procedures.
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
- •Age ≥ 18 ans
- •Weight ≥ 37,5 kg
- •Patients operated for
- •complex endovascular aortic aneurysm repair
- •deep vein recanalization
- •complex arterial revascularization (TASC D lesions)
- •Patient informed of the study details and who didn't opposed to participate in this research
排除标准
- •Known allergy to heparin
- •Known hepatic insufficiency with repercussion on coagulation
- •Thrombocytopenia
- •Known hemostasis disorders
- •Anemia defined HB<8 g/L
- •Pregnant women
- •Persons deprived of their liberty by a judicial or administrative decision
- •Persons subject to psychiatric care
- •Persons admitted to a health or social establishment for purposes other than research
- •Adults subject to a legal protection measure (guardianship, curatorship)
结局指标
主要结局
Correlation between ACT (second) realized in operative room and Anti Xa activity (UI/ml) results provide by the lab.
时间窗: During surgery - 1 day
Following the heparin administration protocol, each ACT measurement will be associated to a blood samples for anti Xa activity measurement. Retrospectively, anti Xa results will be analyze and compare to ACT value which will be report in the operative report. The blood samples will be taken in operative room during endovascular procedures as defined in the protocol.
次要结局
未报告次要终点