Oncologic Diseases, Coagulation Defect, Pain Management
Conditions
Keywords
Direct Oral Anticoagulants (DOACs), Optalgin
Brief summary
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
Detailed description
Evaluation of the Effect of metamizole (Optalgin®) on Anti-Xa Levels in Oncology Patients Receiving Direct Oral Anticoagulants (DOACs)
Interventions
DRUGmetamizole
chronic metamizole use
Sponsors
Rambam Health Care Campus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult oncology patients (≥18 years old). * Receiving apixaban or rivaroxaban for anticoagulation. * New/current metamizole users taking at least 1g TID for pain management. * Platelets ≥100×10⁹/L * ECOG PS\<3 * Provided informed consent
Exclusion criteria
* History of allergic reaction to metamizole or DOACs. * Individuals with significant gastrointestinal disorders that may affect absorption, including (but not limited to) diagnosed bowel obstruction, persistent diarrhea, or the presence of a nasogastric tube (NGT/zonda)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DOAC | 1- Baseline 2- End Of Treatment 3- Day 3 Post treatment 4- Day 5 Post Treatment 5- Day 7 Post treatment | Change in DOAC peak and trough concentrations during periods with and without metamizole comedication (5 different time points). |
Countries
Israel
Contacts
CONTACTLiat Rappaport
Outcome results
None listed