Study Protocol: Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: metamizole, metamizole.
- Who it may be relevant to
- Registry conditions: Oncologic Diseases, Coagulation Defect, Pain Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Metamizole (Optalgin®) on Anti-Xa Concentrations in Oncology Patients Receiving DOACs
Overview
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
- Drug metamizole
chronic metamizole use - Drug metamizole
New metamizole users
Primary outcome measures
- Change in DOAC [Time frame: 1- Baseline 2- End Of Treatment 3- Day 3 Post treatment 4- Day 5 Post Treatment 5- Day 7 Post treatment]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Israel · 1 center
- Rambam Health Care Campus — Haifa
Identifiers
NCT: NCT07384013 · 0268-25-RMB