No registrations found.
ID
Source
Brief title
Health condition
short bowel syndrome, thrombosis, catheter related thrombosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcomes after one year, related to the laboratory levels per subject:
* Efficacy: venous thromboembolism, cerebrovascular stroke
* Safety: (major) bleeding cfr. ISTH criteria, mortality
Secondary outcome
Laboratory outcomes:
* Inter- and intraindividual variability of rivaroxaban absorption
* Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS
Quality of life assessment
* SF-36 questionnaire
Background summary
Rationale
Short bowel syndrome patients are patients at high risk for thrombosis ánd bleeding. In a recent retrospective cohort of 266 patients, 11% developed a recurrent thrombosis and 4.3% developed a bleeding complication within one year. In recent years, direct oral anticoagulants (DOACs) have emerged as a first-line option for the treatment and prevention of venous thromboembolism. A prior pilot study showed that the DOAC rivaroxaban is well absorbed in most patients, but not in all. Therefore in AMC patients with short bowel syndrome, with a lifelong indication for anticoagulation who are prescribed rivaroxaban 20 mg 1dd1, regular “absorption checks” are performed as clinical routine to assure that the adequate plasma levels are obtained . However, in this specific patient population there is no data yet on clinical outcomes showing the relation between the DOAC plasma levels and therapeutic efficacy. This study is conducted to test the following hypotheses:
1) Adequate plasma levels (anti Xa levels and drug concentration) of rivaroxaban 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.
Objective
1) To evaluate attained rivaroxaban plasma levels, assessed anti Xa levels and drug concentration, in patients with short bowel and to relate these blood levels to clinical outcomes.
2) To evaluate the change in quality of life in this patient population.
Study design and population
We choose to perform a prospective cohort drug study with minimally invasive measurements where patients with short bowel syndrome who are taking rivaroxaban according to clinical routine will be observed during a period of at least one year. Patients ≥ 18 years old are eligible for the study if they are diagnosed with SBS by the AMC outpatient clinic endocrinology, if they have a DOAC-registered indication for life long anticoagulants (atrial fibrillation, thromboprophylaxis and treatment of VTE) and if they have no contra-indications for DOAC’s. The invasive measurements consist of 12 extra blood drawls and 2 SF-36 quality of life questionnaires over a period of half a year. The intervention is not the prescribing of rivaroxaban as rivaroxaban is prescribed for the indication which it was registered for.
Main study parameters/endpoints:
- Clinical outcomes: VTE, bleeding, mortality- Laboratory outcomes: anti Xa levels and plasma concentrations of rivaroxaban
- SF-36 questionnaire
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no specified burden or risks associated with participation, as in clinical scenario the same assessments would be done, except for 4 extra blood drawls per day (and filling in two SF-36 questionnaires on quality of life. As it is a drug study, a moderate risk has been assigned to this study.
Study objective
Rivaroxaban in patients with short bowel syndrome is absorbed well and improves quality of life.
Study design
T0 = baseline
T1 = 3 months
T2 = 6 months
Intervention
Blood samples (pharmacokinetic profile) and quality of life questionnaires
Afdeling: vasculaire geneeskunde
Meibergdreef 9, kamer F4-139
Amsterdam 1105AZ
The Netherlands
020-5667516
r.bavalia@amc.uva.nl
Afdeling: vasculaire geneeskunde
Meibergdreef 9, kamer F4-139
Amsterdam 1105AZ
The Netherlands
020-5667516
r.bavalia@amc.uva.nl
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following 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 before the start of TPN (DOAC, vitamin K antagonist, heparin) such as stroke prevention in patients with atrial fibrillation, prevention of venous thromboembolic events
Exclusion criteria
3. 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 anticoagulant
o Chronic treatment with NSAID/Cytochrome P450/PgP dependent co-
medication
o Severe renal (eGFR<15) or hepatic impairment (Child Pugh score B or C) o Pregnancy or inadequate use of contraception
Gastrectomy or
- 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
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7225 |
| NTR-old | NTR7425 |
| Other | METC Amsterdam UMC // ABR Toetsingonline : 2018_84 // NL63863.018.18 |