short bowel syndrome, thrombosis, catheter related thrombosis
Conditions
Interventions
Blood samples (pharmacokinetic profile) and quality of life questionnaires
Sponsors
Amsterdam University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Diagnosis of short bowel syndrome (<170 cm after Treitz ligamentum) or intestinal malabsorption, diagnosed by an endocrinologist in the AMC - Current use of TPN - Age 18 years or over - Indication for anticoagulant therapy before the start of TPN (DOAC, vitamin K antagonist, heparin) such as stroke prevention in patients with atrial fibrillation, prevention of venous thromboembolic events
Exclusion criteria
Exclusion criteria: 3. Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study - Symptomatic thrombosis at inclusion - Major bleeding defined according to the International Society on Thrombosis and Haemostasis(11) in the 6 months prior to start participation - Contraindication for direct oral anticoagulant o Chronic treatment with NSAID/Cytochrome P450/PgP dependent co- medication o Severe renal (eGFR<15) or hepatic impairment (Child Pugh score B or C) o Pregnancy or inadequate use of contraception Gastrectomy or - Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than six months, or unwillingness to sign informed consent; - Non-compliance or inability to adhere to treatment or to the follow-up visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcomes after one year, related to the laboratory levels per subject: *Efficacy: venous thromboembolism, cerebrovascular stroke *Safety: (major) bleeding cfr. ISTH criteria, mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory outcomes: * Inter- and intraindividual variability of rivaroxaban absorption * Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS Quality of life assessment * SF-36 questionnaire | — |
Contacts
Public ContactRoisin Bavalia
Outcome results
None listed