Effect of Smoking on Activated Clotting Time Values During Coronary Angioplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- ACT values after injection the second injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients
研究概览
简要总结
analyzing influence of smoking on patients anti-coagulation status as assessed by ACT measurements during coronary angioplasty
详细描述
During angioplasty, activated clotting time (ACT) measurements are recommended to attest the correct anticoagulation level and if anticoagulation levels are suboptimal after the two first boluses, additional unfractionated heparin (UFH) injections are recommended until obtention of a therapeutic ACT values (250-350s).
The study hypothesis was that the procoagulant effect of the tobacco may be responsible of reduced anticoagulation levels after standardized UFH administrations and thus presenting an UFH resistance requiring increased UFH dosages to obtain a therapeutic ACT values.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment
排除标准
- •unconscious patient
- •any patient presenting with one of the following characteristic known to impact either on ACT or aPTT measurements as: oral anticoagulation medication (anti-vitamin K and non-vitamin K antagonist oral anticoagulants [NOAC]), fondaparinux or LMWH usage, coagulopathy defined as prothrombin time < 50 % or thrombopenia < 50 000 G/L, declared or observed thrombophilia defined as antithrombin < 50%, baseline aPTT values with a ratio patient/control > 1.2 presence of lupus anticoagulant, connective tissue disease, active cancer
- •a person as defined by the law articles L. 1121-5, L. 1121-7 et L1121-8 of the Code de la santé publique, France (pregnant, parturient women or breastfeeding women, legally adult patient under legal protection measure [tutelage, protection of vulnerable adults]),
- •a person as defined by the law articles L. 3212-1 et L. 3213-1 of the Code de la santé publique, France (legally adult patient unable to consent, person with legal or administrative freedom restriction or person under psychiatric treatment)
结局指标
主要结局
ACT values after injection the second injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients
时间窗: immediately after the intervention
comparison of ACT values after injection of two standardized UFH boluses between non-smoking and actively smoking patients (non-smoker group versus active smoker group)
ACT values after injection the first injection of a standardized unfractionated heparin bolus between non-smoking and actively smoking patients
时间窗: during the intervention
comparison of ACT values after injection of two standardized UFH boluses between non-smoking and actively smoking patients (non-smoker group versus active smoker group)
次要结局
- ACT values after injection of the second standardized UFH bolus in ex-smokers(immediately after the intervention)
- ACT values after injection of the first standardized UFH bolus in ex-smokers(during the intervention)
研究者
Pr Camenzind
Principal Investigator
Central Hospital, Nancy, France