Pilot-Trial: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications
研究概览
简要总结
Patients with severe heart failure supported by left ventricular assist device (LVAD) require adequate long-term anticoagulant therapy. New oral anticoagulants such as the direct thrombin inhibitor dabigatran may represent an alternative to Coumarin for long-term anticoagulation.
In this pilot single-center study, thirty LVAD patients with stable renal function were scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after implantation of a HeartWare HVAD system following an open-label balanced parallel group design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •LVAD (HVAD, Heartware Inc., Framingham, MA, USA) implantation more than one month ago
- •Stable renal function (clinical judgement)
- •Age 18 years or older
- •Ability to give informed consent
排除标准
- •Severe chronic renal impairment (CL<30)
- •History of significant thromboembolic events
- •Significant bleeding disorder
- •HIV or Hepatitis C infection
- •Heparin induced thrombocytopenia
- •Known hypersensitivity to Dabigatran or Phenprocoumon
研究组 & 干预措施
study medication
Dabigatran 110mg twice daily with normal renal function (glomerular filtration rate >80 ml/min) Dabigatran 75mg twice daily with impaired renal function (glomerular filtration rate between 80 and 30 ml/min)
干预措施: Dabigatran (Drug)
control group
Phenprocoumon dosage according to INR
干预措施: Phenprocoumon (Drug)
结局指标
主要结局
Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications
时间窗: through study completion, an average of 1 year
Number of major and minor bleeding events (INTERMACS definition)
时间窗: through study completion, an average of 1 year
an episode of internal or external bleeding that results in death, the need for re-operation or hospitalization; or necessitates transfusion of red blood cells
Number of patients with necessary treatment changes
时间窗: through study completion, an average of 1 year
Patient contentment (regular assessment with questionnaire)
时间窗: Change of Baseline Patient Contentment at 12 months
次要结局
- Treatment effects on Glomerular Filtration Rate (GFR; renal parameter)(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
- Treatment effects on INR (coagulation parameter)(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
- Treatment effects on TT (thrombin clotting time; coagulation parameter)(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
- Treatment effects on Pump Flow (pump parameter), measured in L/min(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
- Treatment effects on PTT (activated partial thromboplastin time; coagulation parameter)(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
- Treatment effects on Creatinine (renal parameter)(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
- Treatment effects on Pump Speed (pump parameter), measured in RPM(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
- Treatment effects on Pump Pulsatility (pump parameter), measured in L/min(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
- Treatment effects on Pump Power (pump parameter), measured in W(2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion)
研究者
Daniel Zimpfer, MD
MD; Associate Professor of Cardiac Surgery; Principal Investigator
Medical University of Vienna