Bleeding, Thrombosis
Conditions
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.
Interventions
DRUGDabigatran
DRUGPhenprocoumon
Sponsors
Daniel Zimpfer, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient contentment (regular assessment with questionnaire) | Change of Baseline Patient Contentment at 12 months | — |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 | — |
| 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 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 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 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 |
Countries
Austria
Outcome results
None listed