How well is the blood thinner apixaban absorbed in people with short bowel syndrome?
| ISRCTN | ISRCTN80601124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80601124 |
| Secondary identifying numbers | MH CZ-DRO-VFN64165 |
- Submission date
- 02/07/2025
- Registration date
- 03/07/2025
- Last edited
- 03/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Patients with short bowel syndrome (SBS) may not absorb medications normally due to reduced intestinal surface area. This study aims to find out whether a common blood thinner called apixaban is absorbed well in patients with SBS.
Who can participate?
Patients aged 18 years and over with SBS who are stable and already receiving apixaban as part of their routine care.
What does the study involve?
Participants attend one visit during which blood samples are taken at specific times after their morning dose of apixaban. No other procedures or treatments are involved.
What are the possible benefits and risks of participating?
There is no direct benefit to participants, but the results may help guide future dosing recommendations. Risks are minimal and limited to blood sampling.
Where is the study run from?
The study is being conducted at the 4th Department of Internal Medicine, General University Hospital in Prague, Czech Republic.
When is the study starting and how long is it expected to run for?
June 2023 to April 2025
Who is funding the study?
The study is funded by the Ministry of Health of the Czech Republic (project MH CZ-DRO-VFN64165)
Who is the main contact?
Dr Karolína Hronová, karolina.hronova@lf1.cuni.cz
Contact information
Public, Scientific, Principal Investigator
Albertov 4
Prague 2
12800
Czech Republic
 ORCID ID |
0000-0002-1073-0854 |
|---|---|
| Phone | +420 (0)224968113 |
| karolina.hronova@lf1.cuni.cz |
Study information
| Study design | Single-center non-randomized single-arm observational pharmacokinetic study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Pharmacokinetic profiling of apixaban in patients with short bowel syndrome using Bayesian re-estimation of a published population pharmacokinetic model |
| Study acronym | Api for SBS |
| Study objectives | To determine whether the pharmacokinetics of apixaban in patients with short bowel syndrome differ from those in patients with intact gastrointestinal tracts, using Bayesian re-estimation of a published population pharmacokinetic model. |
| Ethics approval(s) |
Approved 15/06/2023, Ethics Committee of the General University Hospital in Prague (Na Bojisti 1, Prague 2, 12808, Czech Republic; +420 (0)224 964 131; etickakomise@vfn.cz), ref: 700/73 |
| Health condition(s) or problem(s) studied | Short bowel syndrome (SBS) |
| Intervention | Blood samples were obtained to capture the expected peak plasma steady state concentrations (Tmax) of apixaban in outpatients on standard dose as recommended by the treating physician, in accordance with SmPC, following two different sampling schedules: one sample collected 30 minutes prior to single-dose administration and additional samples at 1, 2.5, 3 and 4.5 hours post-dose of the standard apixaban regimen. |
| Intervention type | Other |
| Primary outcome measure | Plasma concentration of apixaban measured by LC-MS/MS at 30 minutes before morning dose, followed by post-dose samples at 1 ± 0.5, 2.5 ± 0.5, 3 ± 0.5, and 4.5 ± 0.5 hours on the day of steady-state sampling |
| Secondary outcome measures | 1. Relationship between apixaban concentrations and clinical covariates (e.g. nutritional status, parenteral nutrition, teduglutide use, bilirubin) assessed on the day of PK sampling 2. Variability in pharmacokinetic parameters calculated using Bayesian re-estimation |
| Overall study start date | 15/06/2023 |
| Completion date | 01/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 13 |
| Total final enrolment | 13 |
| Key inclusion criteria | 1. Adults with SBS type 1–3 2. Clinically stable 3. Receiving apixaban chronically 4. Able to provide informed consent |
| Key exclusion criteria | 1. Age <18 years 2. Pregnancy or lactation 3. Body mass index (BMI) <18 kg/m² 4. Active IBD 5. Liver failure (Child-Pugh C) 6. <6 weeks after resection 7. Hemodialysis |
| Date of first enrolment | 23/09/2023 |
| Date of final enrolment | 30/03/2025 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
U Nemocnice 2
Prague
12808
Czech Republic
Sponsor information
Hospital/treatment centre
U Nemocnice 2
Prague 2
12808
Czech Republic
| Phone | +420 (0)224961111 |
|---|---|
| martina.rackova@vfn.cz | |
| Website | https://www.vfn.cz |
"ROR" |
https://ror.org/04yg23125 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in peer-reviewed journal |
| IPD sharing plan | The dataset generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
03/07/2025: Study's existence confirmed by the Ethics Committee of the General University Hospital in Prague.
