RIVAROXABAN for Short bowel syndrome

Inclusion criteria

• {"criterion_text":"- diagnosis of short bowel syndrome (<170cm after Treitz ligamentum) or intestinal malabsorption, diagnosed by an endocrinologist in the AMC"}
• {"criterion_text":"- Current use of Total Parenteral Nutrition"}
• {"criterion_text":"- Age 18 years or over"}
• {"criterion_text":"- Indication for anticogulant therapy before the start of TPN (DOAC, vit K antagonist, heparin) such as stroke prevention in patient with atrial fibrillation, prevention of venous thromboembolic events"}

Exclusion criteria

• {"criterion_text":"- Systomatic thrombosis at inclusion"}
• {"criterion_text":"- Major bleeding defined according to the ISTH in the 6mnths prior to start particiupation"}
• {"criterion_text":"- Contraindication for direct oral anticoagulant"}
• {"criterion_text":"- Gastrectomy or short-bowel syndrome <30cm after Treitz ligamentum"}
• {"criterion_text":"- Medical of psychological condition that would not permit completion of the study or signing of informed consent"}
• {"criterion_text":"- Non-compliance or inability to adhere treatment or to the follow-up visits"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Clinical outcomes after one year per subject (efficacy: venous thromboembolism, cerebrovascular stroke; safety: (major) bleeding per ISTH criteria, mortality). Laboratory outcomes include correlation between anti-Xa levels and rivaroxaban plasma concentrations as assessed by LC-MS/MS. Quality of life measured by SF-36."}

Secondary endpoints

• {"endpoint_text":"- iii. Other study parameters Baseline characteristics will be collected; * Age * Sex","definition_or_measurement_approach":"Baseline characteristics collection including age and sex."}

Other endpoints

• {"endpoint_text":"- * Inter- and intraindividual variability of rivaroxaban absorption","definition_or_measurement_approach":""}
• {"endpoint_text":"- * Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS","definition_or_measurement_approach":"Rivaroxaban plasma concentrations assessed by LC-MS/MS and correlated with anti-Xa levels."}
• {"endpoint_text":"- * SF-36","definition_or_measurement_approach":"Quality of life assessment using the SF-36 instrument."}

Netherlands

Latest Decision Or Authorization Date

22-11-2024

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands