Evaluation of how well rivaroxaban is absorbed in patients with short bowel syndrom, based on laboratory markers and clinical outcomes such as thrombosis and bleeding.
- Conditions
- Chronic intestinal failuyre (IF) is caused by large surgical bowel resection, severe motility, or absorption diseorders. These patientds require partial or total parenteral nutrition (PN and TPN, respectively) and are thereby critically dependent on maintaining venous acces withj central venous catheter (CVC). CVC-related thrombosis is a frequent and serious complication that leads to catheter failure and is associated with CVC-infections and sepsis.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-001845-15-NL
- Lead Sponsor
- Academic medical centre, department of internal medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- 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 before the start of TPN (DOAC, vitamin K antagonist, heparin) such as stroke prevention in patients with atrial fibrillation, prevention of venous thromboembolic events
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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 anticoagulant
oChronic treatment with NSAID/Cytochrome P450/PgP dependent co-
medication
oSevere 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method