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)
- Conditions
- short bowel syndrome1002547710014523
- Registration Number
- NL-OMON48704
- Lead Sponsor
- Vasculaire Geneeskunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
-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
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
than six months, or unwillingness to sign informed consent;- Non-compliance or
inability to adhere to treatment or to the follow-up visits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameters are the clinical outcomes: VTE for efficacy and<br /><br>bleeding/mortality for safety measurement</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are<br /><br>- the correlation of the differen laboratory outcomes wtih one another; anti<br /><br>Xa levels and LC MS/MS for determination of rivaroxaban levels.<br /><br>- effectiveness of change of anticoagulants on the quality of life within this<br /><br>complicated patient population </p><br>