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)

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48704

Enrollment

Registered

2018-06-18

Start date

2018-09-25

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

short bowel syndrome

Interventions

Drug study phase IV --> pharmacodynamics and kinetics are evaluated in patients with short bowel syndrome by several blood drawls

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The primary study parameters are the clinical outcomes: VTE for efficacy and bleeding/mortality for safety measurement	—

Secondary

Measure	Time frame
Secondary outcomes are - the correlation of the differen laboratory outcomes wtih one another; anti Xa levels and LC MS/MS for determination of rivaroxaban levels. - effectiveness of change of anticoagulants on the quality of life within this complicated patient population	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)