left ventricular assist device (lvad) specialized centers of clinically orientated research (sccor) coagulation - acute intrinsic pathway antagonist (ipa)

Conditions: Coagulation

Summary: the purpose of this study is to determine if post-operative administration of intrinsic pathway antagonist (ttp889) in patients on left ventricular assist device (lvad) support will result in a 50% reduction of thrombin generation markers at 28 days compared to placebo.


Eligibility criteria:
inclusion criteria: * signed informed consent, release of medical information, and hipaa forms * age greater than or equal to 18 years * male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test * implanted with an fda-approved lvad (for btt or dt indication, e.g. heartmate® xve) within 72 hours prior to randomization, and able to receive the first dose of study drug by 72 hours (+6 hours) post lvad implantation * post-op hemostasis adequate for starting low level anticoagulation (as assessed by surgeon) * extubated and able to take oral medication exclusion criteria: * evidence of active bleeding within 24 hours prior to randomization * history of a platelet disorder, including but not limited to thrombocytopenia and thrombasthenia * thrombocytopenia with platelets \<80,000/ml within 48 hours prior to randomization * history of an inherited or acquired coagulation disorder * hemoglobin \<8 g/dl (4.85 mmol/l) or hematocrit \<26% within 24 hours prior to randomization * clinical indication for (or the intention to use) standard anticoagulation therapy at time of randomization (e.g., atrial fibrillation or dvt) * intention to treat with more than 325 mg aspirin daily * any clinical requirement or intention to treat with phenytoin, tolbutamide or warfarin post randomization * rvad support at the time of randomization * estimated glomerular filtration rate (gfr) ≤30 ml/min (by cockcroft-gault formula), or any form of dialysis within 48 hours prior to randomization * evidence of intrinsic hepatic disease as defined as biopsy proven liver cirrhosis; or liver enzyme values (ast or alt) that are \>3 times the upper limit of normal; or total bilirubin \>1.5 times the upper limit of normal (with the exception of gilbert's syndrome) within 3 days prior to randomization * active systemic infection, in the judgment of the investigator, within 3 days prior to randomization * stroke or transient ischemic attack (tia) within 6 months prior to randomization * history of intracranial hemorrhage or gastrointestinal bleed within 3 months prior to randomization * alzheimer's disease, or any other form of irreversible dementia * history of psychiatric disease (including drug or alcohol abuse) that may impair compliance with the study protocol * pregnant or breastfeeding at time of randomization * received investigational intervention within 30 days prior to randomization * body weight \< 45 kg

Keywords: left ventricular assist devices cardiac disease heart failure anticoagulant for left ventricular assist devices