parenteral nutrition, thrombosis, pharmacokinetics, pharmacodynamics, anticoagulant
Conditions
Interventions
In a cross-over design, patients will be treated with either rivaroxaban 20 mg once daily for five days or dabigatran etexilate 150 mg twice daily for five days. Between the two treatment periods, a w
Sponsors
Academic Medical Center, Amsterdam, The Netherlands
Eligibility
Inclusion criteria
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: Exclusion criteria are: - moderate/severe renal impairment (CKD EPI Creatinine Clearance 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 not currently on anticoagulant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the assessment of PK and PD parameters of the two drugs and the comparison to published values. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is the comparison between rivaroxaban PK parameters and dabigatran PK parameters (AUC, Cmax and Tmax). | — |
Contacts
Public ContactS. Middeldorp
Academic Medical Center (AMC), Department of Vascular Medicine, F4-276, P.O. Box 22660
Outcome results
None listed