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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)
EU CTIS ID: 2024-519078-38-00
What this study is testing
The main aim of this study is to assess the clinical outcomes of this patient population treated with long-term parenteral nutrition and taking rivaroxaban and to relate these clinical outcomes to the laboratory assessments. The primary outcomes are the clinical outcomes after at least one year an the (varibaility in the) laboratory concentrations
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- diagnosis of short bowel syndrome (<170cm after Treitz ligamentum) or intestinal malabsorption, diagnosed by an endocrinologist in the AMC
- Current use of Total Parenteral Nutrition
- Age 18 years or over
- 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
You likely can't join if
- Systomatic thrombosis at inclusion
- Major bleeding defined according to the ISTH in the 6mnths prior to start particiupation
- Contraindication for direct oral anticoagulant
- Gastrectomy or short-bowel syndrome <30cm after Treitz ligamentum
- Medical of psychological condition that would not permit completion of the study or signing of informed consent
- Non-compliance or inability to adhere treatment or to the follow-up visits
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.