This study has been transitioned to CTIS with ID 2024-519078-38-00 check the CTIS register for the current data. 1) To evaluate the efficacy and safety of the standard clinical care at the AMC in this patient population by the clinical outcomes (…
ID
Source
Brief title
Condition
- Malabsorption conditions
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the clinical outcomes: VTE for efficacy and
bleeding/mortality for safety measurement
Secondary outcome
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
Background summary
In the AMC, patients with short bowel syndrome with a lifelong indication for
anticoagulation are prescribed Rivaroxaban 20 mg 1dd1 for the registered
indications. Extra *resorption checks* are conducted in clinical practise to
make sure the plasma levels are within the reference values. However there is
no data yet on clinical outcomes showing the relation between the DOAC plasma
levels and disease outcome. Therefore we want to conduct this study. Our
hypothesis is
1) Adequate plasma levels of Rivaroxaban (anti Xa levels) in a patient
population suffering from short bowel syndrome correlate with favorable
clinical outcomes, in particular less recurrent thrombosis.
2) Rivaroxaban in patients suffering from short bowel syndrome who have a
lifelong indication for anticoagulants leads towards improvement of quality of
life.
Study objective
This study has been transitioned to CTIS with ID 2024-519078-38-00 check the CTIS register for the current data.
1) To evaluate the efficacy and safety of the standard clinical care at the AMC
in this patient population by the clinical outcomes (recurrent) thrombotic
events and bleeding complications respectively.
2) To evaluate the change in quality of life in this patient population.
Study design
We choose to perform a prospective observational cohort study with invasive
measurements where patients with short bowel syndrome taking rivaroxaban will
be observed during a period of one year.
Intervention
Drug study phase IV --> pharmacodynamics and kinetics are evaluated in patients
with short bowel syndrome by several blood drawls
Study burden and risks
There are no specified burden or risks associated with participation, as in
clinical scenario the same assessments would be done, except for an extra 12
blood drawls over a periode of 6 months (+ filling in two SF-36 questionnaires
on quality of life. The extra blood drawls per day does mean that the patient
is asked to stay in the hospital for another two hours longer, compared to
standard clinical care.
Meibergdreef 9 9
Amsterdam-Zuidoost 1105AZ
NL
Meibergdreef 9 9
Amsterdam-Zuidoost 1105AZ
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-519078-38-00 |
| EudraCT | EUCTR2018-001845-15-NL |
| CCMO | NL63863.018.18 |