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 个研究点目标入组 30 人开始时间: 2018年6月27日最近更新: 2021年4月5日

试验速览

暂无简介。

•-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.

发起方

Academic medical centre, department of internal medicine