EvaluaTion of Clinical and laboratory outcomes of Rivaroxaban in short Bowel syndrome patients dEpending on Long term parenteral nutrition: a prospective cohort study
- Conditions
- short bowel syndrome, thrombosis, catheter related thrombosis
- Registration Number
- NL-OMON28143
- Lead Sponsor
- Amsterdam University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria
3. Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical outcomes after one year, related to the laboratory levels per subject:<br /><br><br>*Efficacy: venous thromboembolism, cerebrovascular stroke<br /><br><br>*Safety: (major) bleeding cfr. ISTH criteria, mortality<br>
- Secondary Outcome Measures
Name Time Method aboratory outcomes:<br /><br><br>*Inter- and intraindividual variability of rivaroxaban absorption<br /><br>*Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS<br /><br><br /><br>Quality of life assessment<br /><br><br>*SF-36 questionnaire<br>