Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia. A Prospective Randomized Controlled Academic Single-centre Feasibility Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Primary Safety Outcome is the occurence of clinically-relevant bleeding events
研究概览
简要总结
Safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with staphylococcus aureus bacteraemia.
The study hypothesizes that inhibition of the coagulase-activity of S. aureus by direct thrombin inhibitors is safe and translates into a better outcome of patients with S. aureus bacteremia.
详细描述
Single center randomized controlled trial of direct thrombin inhibitors versus standard enoxaparin.
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Feasibility: proportion of patients eligible for randomization; clinically attained concentration of DTI and resulting staphylothrombin inhibition
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Safety: bleeding events (major/ clinically relevant non-major)
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Efficacy: thrombotic events during the thromboprophylactic treatment + 3 days
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Secondary outcome measures
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Coagulation parameters: evolution of D-dimers from day 0-4; other lab parameters of coagulation (PT/APTT/fibrinogen/platelet count)
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Inflammatory parameters: CRP, white blood cell count, neutrophilia
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Clinical outcomes: metastatic infections, assessed clinically or by PET/CT; relapse of S. aureus bacteremia; defervescence; persistent positive blood cultures; hospital stay, mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Positive blood culture for staphylococcus aureus
- •Symptoms or signs of infection
- •Indication for thromboprophylaxis
排除标准
- •Contraindication for thromboprophylaxis
- •Significant active bleeding or risk of excessive bleeding
- •Heparin-induced thrombocytopenia
- •Severe liver and kidney disease
- •Pregnancy and lactation.
研究组 & 干预措施
enoxaparin
enoxaparin 40 mg od, sc
干预措施: enoxaparin (Drug)
direct thrombin inhibition
dabigatran 110 mg BID, po argatroban (0.5 - 1 µg/kg/min) if peroral therapy is not possible
干预措施: direct thrombin inhibition (Drug)
结局指标
主要结局
Primary Safety Outcome is the occurence of clinically-relevant bleeding events
时间窗: From date of randomization up to end of study drug + 3 days
次要结局
- The primary efficacy outcome is the occurence of metastatic infection(From randomization until month 3)
研究者
Peter Verhamme
Prof.
Universitaire Ziekenhuizen KU Leuven