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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Medical Univerity Vienna
Vienna, Vienna, Austria
Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications
Time frame: through study completion, an average of 1 year
Number of major and minor bleeding events (INTERMACS definition)
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
Time frame: through study completion, an average of 1 year
Number of patients with necessary treatment changes
Time frame: through study completion, an average of 1 year
Patient contentment (regular assessment with questionnaire)
Time frame: Change of Baseline Patient Contentment at 12 months
Treatment effects on INR (coagulation parameter)
measured via a blood test
Time frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
Treatment effects on TT (thrombin clotting time; coagulation parameter)
measured via a blood test
Time frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
Treatment effects on Glomerular Filtration Rate (GFR; renal parameter)
measured via a blood test
Time frame: 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
Time frame: 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)
measured via a blood test
Time frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
Treatment effects on Creatinine (renal parameter)
measured via blood test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after inclusion
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