anticoagulant blood thinner
Conditions
Interventions
Rivaroxaban and dabigatran etexilate will be used in the commercially available
formulation and will be obtained through the pharmacy of the Academic Medical
Center. Batchnumbers of medication will
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
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 that are not being treated with any 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). PK Parameters - rivaroxaban plasma concentration (liquid chromatography-mass spectrometry; LC-MS/MS), - dabigatran plasma concentration (liquid chromatography-mass spectrometry; LC-MS/MS). Pharmacokinetic parameters will be calculated by non-compartmental analysis. The following parameters will be obtained: Tmax (time of maximal concentration), Cmax (maximal concentration), AUC (area under the plasma versus time curve (dabigatran: 0-12 h, rivaroxaban: 0-24h), CL/F (oral clearance), V/F (volume of distribution) and T1/2 (elimination half life). AUC, Cmax and Tmax will compared to published values. PD parameters - aPTT (dabigatran), - Neoplastin Plus PT (Diagnostica Stago, Asnières, France) (rivaroxaban), - calibrated quantitative anti-factor Xa assay (STA Rotachrom*method, Diagnostica Stago, Asnières-sur-Seine, France) (rivaroxaban), - Hemoclot thrombin inhibitor assay (HYPHEN BioMed, Neuville-sur-Oise, France) (dabigatran). | — |
Countries
Netherlands
Outcome results
None listed