short bowel syndrome
Conditions
Brief summary
i. Main study parameter/endpoint Clinical outcomes after one year, related to the laboratory levels per subject: * Efficacy: venous thromboembolism, cerebrovascular stroke * Safety: (major) bleeding cfr. ISTH criteria, mortality ii. Secondary study parameters/endpoints * Inter- and intraindividual variability of rivaroxaban absorption Laboratory outcomes: * Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS Quality of life assessment * SF-36
Detailed description
iii. Other study parameters Baseline characteristics will be collected; * Age * Sex
Interventions
Sponsors
Amsterdam UMC Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i. Main study parameter/endpoint Clinical outcomes after one year, related to the laboratory levels per subject: * Efficacy: venous thromboembolism, cerebrovascular stroke * Safety: (major) bleeding cfr. ISTH criteria, mortality ii. Secondary study parameters/endpoints * Inter- and intraindividual variability of rivaroxaban absorption Laboratory outcomes: * Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS Quality of life assessment * SF-36 | — |
Secondary
| Measure | Time frame |
|---|---|
| iii. Other study parameters Baseline characteristics will be collected; * Age * Sex | — |
Countries
Netherlands
Outcome results
None listed