Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)
- Registration Number
- NCT02872649
- Lead Sponsor
- Daniel Zimpfer, MD
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group Phenprocoumon Phenprocoumon dosage according to INR study medication Dabigatran 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)
- Primary Outcome Measures
Name Time Method Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications through study completion, an average of 1 year Number of major and minor bleeding events (INTERMACS definition) 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 through study completion, an average of 1 year Patient contentment (regular assessment with questionnaire) Change of Baseline Patient Contentment at 12 months
- Secondary Outcome Measures
Name Time Method Treatment effects on Glomerular Filtration Rate (GFR; renal parameter) 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion measured via a blood test
Treatment effects on INR (coagulation parameter) 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion measured via a blood test
Treatment effects on TT (thrombin clotting time; coagulation parameter) 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion measured via a blood test
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 Creatinine (renal parameter) 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion measured via blood test
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 PTT (activated partial thromboplastin time; coagulation parameter) 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion measured via a blood test
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
Trial Locations
- Locations (1)
Medical Univerity Vienna
🇦🇹Vienna, Austria