ew medication for the prophylaxis of thrombosis in patients with mechanical heart support

Phase 1

Conditions: patients with implanted left ventricular assist device
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
MedDRA version: 13.1Level: LLTClassification code 10052374Term: Left ventricular assist device insertionSystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2010-024534-38-AT

Lead Sponsor: Medizinische Universität Wien, Abteilung für Herzchirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

-Planned or recent LVAD (HeartWare, HeartWare International Inc., Framingham, MA, USA) implantation
-Age 18 years or older
-Ability to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

-Severe chronic renal impairment (creatinine clearence (CLCR) <30ml/min)
-History of significant major thromboembolic events
-Significant bleeding disorder
-HIV or Hepatitis C infection
-Heparin induced thrombocytopenia
-Known hypersensitivity to Dabigatran, Dalteparin or Phenprocoumon

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess safety of Dabigatran administration in LVAD (HeartWare) patients<br><br>;Secondary Objective: 2) To estimate sample size for a multi-center clinical trial<br>3) To evaluate patient contentment in this patient cohort <br>;Primary end point(s): -Number of major (life threatening or leading to chronic disability) and minor adverse events due to thromboembolic complications <br>-Number of major and minor bleeding events (TIMI bleeding classification)<br>-Patient contentment (regular assessment with a questionnaire) <br>-Number of patients with necessary treatment changes<br>;Timepoint(s) of evaluation of this end point: every visit during the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Increase of liver enzymes > 3 times upper limit<br>-Treatment effects on coagulation parameters<br>;Timepoint(s) of evaluation of this end point: every routine blood draw during the study