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

Academic medical centre, department of internal medicine0 sites30 target enrollmentJune 27, 2018

Overview

No summary available.

Registry

who.int

Start Date

June 27, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Academic medical centre, department of internal medicine

•\-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\-
•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.