Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device (LVAD)

Study Overview
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Brief Summary
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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.

Official Title
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Pilot-Trial: Dabigatran as an Alternative Anticoagulant in Patients With Left Ventricular Assist Device

Conditions
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Thrombosis, Bleeding

Intervention / Treatment
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* Drug: Dabigatran
* Drug: Phenprocoumon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study medication<br>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) | Drug: Dabigatran<br> <br> * Other names: Pradaxa;|
| Active Comparator: control group<br>Phenprocoumon dosage according to INR | Drug: Phenprocoumon<br> <br> * Other names: Warfarin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | through study completion, an average of 1 year | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment effects on INR (coagulation parameter) | measured via a blood test | 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 | 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 | 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) | measured via a blood test | 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 | 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 |