Nadroparin Anticoagulation for Continuous Venovenous Hemofiltration (CVVH), a Randomized Cross-over Trial Comparing Hemostasis Between Two Hemofiltration Rates
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.
研究概览
简要总结
The low molecular weight heparin nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. Continuous hemofiltration is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. Accumulation would increase the risk of bleeding.
Aim of the present study is to determine
- whether nadroparin accumulates in plasma
- whether nadroparin is removed by filtration and whether removal depends on hemofiltration dose
- the effects of nadroparin during critical illness on coagulation and anticoagulation
详细描述
The low molecular weight heparin (LMWH) nadroparin is used for anticoagulation of the extracorporeal hemofiltration circuit. LMWH accumulate in patients with chronic renal failure. Continuous venovenous hemofiltration (CVVH) is a renal replacement modality for intensive care patients with acute renal failure. Up to now it is not known whether nadroparin is removed by hemofiltration or not. If not, accumulation is expected and the risk of bleeding for the patient increases. Because critically ill patients are at increased risk of bleeding, this question is crucial.
If nadroparin would be removed by filtration, removal is expected to depend on hemofiltration dose (to be greater with a higher dose)
We therefore designed a randomized controlled cross-over trial in the setting of critical illness and acute renal failure comparing the anticoagulant effect of nadroparin (anti-Xa) between two doses of CVVH in the patients blood, in the extracorporeal circuit and in the ultrafiltrate.
Because hemostasis in critically ill patients is not only influenced by anticoagulation but also by the critical illness and the extracorporeal circuit, we also measure other hemostatic markers, especially the endogenous thrombin potential (ETP), which seems the most global marker of hemostasis, incorporating procoagulant and anticoagulant effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •acute renal failure requiring renal replacement therapy
排除标准
- •(recent) bleeding or a suspicion of bleeding necessitating transfusion,
- •need of therapeutic anticoagulation or
- •(suspected) heparin-induced thrombocytopenia
结局指标
主要结局
Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration.
时间窗: 24 hours
次要结局
- Endogenous thrombin potential, D-dimers, Prothrombin fragments 1-2, thrombin-antithrombin complexes(24 hours)
