Pharmacokinetics and *dynamics of Dabigatran Etexilate and Rivaroxaban in patients requiring PArenteral Nutrition (the PDER PAN study)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

Inclusion criteria are:
- clinically stable adult male and female patients (age between 18 and 75 years),
- body weight between 50 and 100 kg,
- chronic (>3 months) use of home TPN due to short bowel syndrome after surgical resection and small bowel shorter than 160 cm after ligamentum of Treitz, irrespective of the presence of colon,

Exclusion Criteria

Exclusion criteria are:
- moderate/severe renal impairment (CKD EPI Creatinine Clearance < 50 mL/min according to http://www.nephron.com/MDRD_GFR.cgi), or moderate/severe hepatic impairment (class B (7-9 points) or class C (10-15 points) at the Child-Pugh score),
- major bleeding events in the previous 6 months (according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients),
- cytochrome P450 3A4 and/or P-gp-dependent co-medications in the last 14 days (verapamil, azoles, amiodarone, dronedarone, azithromycin, erythromycin, clarythromycin, quinidine, ritonavir, cyclosporine, propafenone, isoniazid, rifampin, rifapentine, primidone, St. John*s wort, carbamazepine, oxcarbazepine, phenobarbital, pentobarbital, nevirapine, nafcillin, fosphenonytoin),
- ongoing anticoagulant treatment for an acute thrombotic event (prior 6 months) or for a condition estimated to be at high risk of recurrence (i.e., presence of mechanical heart valve),
- use of phenprocoumon,
- chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs), or chronic treatment with aspirin (>100 mg/day), or dual antiplatelet therapy,
- current participation in any other investigational drug study or within the past 30 days,
- pregnancy,
- partial or total gastrectomy, and/or resection of the duodenum for any cause,
- presence of any condition that, as judged by the investigator, would place the subject at increased risk of harm if he participated in the study (i.e., recent CVC-related infection, sepsis)
- presence of significant haemostatic abnormalities (i.e., severe thrombocytopenia, severe prolongation of haemostatic tests PT and aPTT) in patients that are not being treated with any anticoagulant.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the assessment of PK and PD parameters of the two drugs<br /><br>and the comparison to published values.</p><br>

Secondary Outcome Measures

Name	Time	Method

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