Evaluation of the Effect of Dextran Sulphate on Anti-Xa Activities Measured in Patients Treated With Unfractionated Heparin in Different Indications-DEXHEP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 8
- 主要终点
- Assess the effect of different reagents containing or not dextran sulphate, on the measurement of anti-Xa for different groups of patients
研究概览
简要总结
The measurement of anti-Xa activity is classically used for the dose adjustement of unfractionated heparin (UFH) treatment and to monitor reversal of UFH by protamine during cardiac surgery with cardiopulmonary bypass (CPB). Three categories of reagents are currently available in France for the measurement of anti-Xa activity: antithrombin-containing reagents (very little used), antithrombin-free reagents and antithrombin-free reagents with dextran sulphate. Significant differences in anti-Xa results based on the reagents used were described, particularly after protamine neutralization in CPB. Indeed, dextran sulphate, contained in some reagents, could dissociate the heparin/protamine complex contributing to the higher levels of anti-Xa with these reagents. The differences observed in these patients are likely related to the presence of platelet factor 4 (PF4) in the samples from either PF4 present in vivo in patients or released in vitro after blood collection. These differences may lead to different therapeutic attitudes, including the re-administration of protamine to neutralize heparin at the end of CBP
详细描述
Any hospitalized patient receiving UFH in the intensive, cardiac surgery and medicine departments of the participating centres will be offered the study by investigator. It will be included in the study after validation of the selection criteria and after collecting its non-opposition. This participation will not change the medical care of the participants.
Patients will be divided into four groups:
- Group 1: patients with cardiac surgery with CBP. Blood samples in the operating room, 5 to 10 minutes after neutralization of heparin by protamine.
- Group 2: patients who had cardiac surgery with CBP, between day 1 and day 5 after surgery.
- Group 3: hospitalized patients in intensive care unit, including patients on extracorporeal life support (ECLS).
Group 4: patients hospitalized in a medical non-intensive care ward.
The response to heparin treatment varies considerably depending on the clinical situation. The results found in one indication are not transposable to another indication. The 4 patient groups will provide a comprehensive response to situations in which heparin is used.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients over the age of 18;
- •Hospitalized patients to receive UFH;
- •No patient opposition.
- •Patients will be divided into four groups:
- •Group 1: patients with cardiac surgery with CBP. Blood samples in the operating room, 5 to 10 minutes after neutralization of heparin by protamine.
- •Group 2: patients who had cardiac surgery with CBP, between day 1 and day 5 after surgery.
- •Group 3: hospitalized patients in intensive care unit, including patients on extracorporeal life support (ECLS).
- •Group 4: patients hospitalized in a medical non-intensive care ward..
排除标准
- •pregnant or lactating women;
- •adults subject to legal protection (safeguarding of justice, guardianship, guardianship), persons deprived of their liberty.
结局指标
主要结局
Assess the effect of different reagents containing or not dextran sulphate, on the measurement of anti-Xa for different groups of patients
时间窗: 5 days
Measure of anti-Xa activity in CTAD plasma
次要结局
- To define factors that influence the results of the biological test "anti-Xa" activity :type of anticoagulant (CTAD or citrate) .(5 days)
- To define factors that influence the results of the biological test "anti-Xa" activity :concentration of platelet factor 4 (PF4) and beta-TG present in plasma(5 days)
- To define factors that influence the results of the biological test "anti-Xa" activity :The indication of treatment(5 days)
- To define factors that influence the results of the biological test "anti-Xa" activity :Patient characteristics including age and sex and if available, creatinine clearance, antithrombin, fibrinogen, platelet count(5 days)