NL-OMON48704
Recruiting
Phase 4
EvaluaTIoN of Clinical and laboratory outcomes of Rivaroxaban in short Bowel syndrome patients dEpending on Long term parenteral nutrition: a prospective cohort study (TINCRBEL study) - TINCRBEL study
Vasculaire Geneeskunde0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- short bowel syndrome
- Sponsor
- Vasculaire Geneeskunde
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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 (DOAC, vitamin K antagonist, heparin)
- •such as stroke prevention in patients with atrial fibrillation, prevention of
- •venous thromboembolic events
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 anticoagulanto Chronic treatment with NSAID/Cytochrome
- •P450/PgP dependent co\-medicationo Severe renal (eGFR\<15\) or hepatic
- •impairment (Child Pugh score B or C) o Pregnancy or inadequate use of
- •contraception\- Gastrectomy or short bowel syndrome \< 30 cm after Treitz
- •ligamentum\- Medical or psychological condition that would not permit completion
- •of the study or signing of informed consent, including life expectancy less
Outcomes
Primary Outcomes
Not specified
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