Anticoagulants, Influenza Vaccines
Conditions
Keywords
Oral anticoagulants, Influenza virus, Influenza vaccine, Pharmacological interference
Brief summary
The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination
Detailed description
The pharmacokinetic and the pharmacodynamic interactions and the possible clinical events connected with the simultaneous administration of Oral Anticoagulants (OA) and the influenza virus vaccine were evaluated in several small studies which yielded conflicting results, thus encouraging additional investigations with prospective studies in order to obtain a more consistent evidence about the safety and efficacy of vaccination against influenza virus in patients on OA Treatment.
Interventions
DRUGInfluenza vaccination
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* OA Treatment * Stable anticoagulation (previous two controls in range) * Presence of indication for Influenza Vaccination * Life expectancy \> 6 months * Signed Informed consent
Exclusion criteria
* Absence of stable anticoagulation * Absence of indication for Influenza Vaccination * Life expectancy \< 6 months * Denied Informed Consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Variations in INR value and in OAT weekly dosage after IV | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy of IV in patients on OAT | — |
Countries
Italy
Outcome results
None listed