Clinical trial NCT00137579: Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy
Official title: Phase IV, Simple Blind, 2-Parallel Groups Randomized Trial to Evaluate the Safety and Effectiveness of the Intramuscular Vs Subcutaneous Route for the Administration of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza Vaccines
Acenocoumarol
Drug Administration Routes
Anticoagulants
Lead sponsor: Catalan Institute of Health
Sponsor class: OTHER_GOV
First posted: 2005-08-30
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Until now, the best administration route of the anti-flu vaccine for patients receiving long term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has not been recommended because it may increase the risk of muscular haematoma. Although this practice is widely extended, no significant differences between the safety of both routes have been found. Some authors, analysing a small group of patients, affirm that the anti-flu vaccine can be administered safely by the intramuscular route on patients receiving long term oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous route without any scientific evidence. Due to this, the investigators have done a clinical trial with the aim of determining the safety and effectiveness of the flu-vaccine intramuscular route in patients receiving long term oral anticoagulation therapy and also to analyse the possible interactions between the vaccine and the oral anticoagulant treatment.

Detailed description: Phase IV, simple blind, 2-parallel groups, multicentric randomized trial where each patient will receive a single dose of the recommended by the WHO anti-flu vaccine for the 2003-2004 period, the control group will receive it subcutaneous and intervention group intramuscular. The assignation to each group will be randomized. The study included 4 basic areas of Barcelona city. Three visits have been scheduled for each patient: moment 0, 24 hours and 10 days after the vaccination, and a 7 month follow up period to control the incidence of the flu.

Eligibility criteria: Inclusion Criteria:

* Patients with oral anticoagulation therapy
* Patients who agree to be vaccinated
* Patients who agree to participate in the study
* Patients older than 18

Exclusion Criteria:

* Allergy or hypersensibility to egg, chicken proteins, any component of the vaccine (neomycin, octoxinol-9 or formaldehyd)
* INR greater than 4 in the past 2 months
* Previous major bleeding
* Patients with dementia or with legal tutoring

Primary outcomes:
measure: local pain (scores greater than 3 in the analogic visual scale of pain)
measure: microbiologically diagnosed flu (yes/no)
measure: International Normalized Ratio (INR) to check the interaction between the vaccine and the oral anticoagulation therapy
Secondary outcomes:
measure: increase of the arm perimeter greater than 1 cm
measure: local elemental skin lesions
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Raval Nord
city: Barcelona
country: Spain
facility: Raval Sud
city: Barcelona
country: Spain
facility: Gotic
city: Barcelona
country: Spain
facility: Casc Antic
Study officials:
affiliation: Catalan Institute of Health
name: Josep Casajuana, Physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Elvira Givert, Nurse
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Josep Franch, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Clara Sala, Nurse
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Miriam Aballi, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Begoña Iglesias, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Joan Antoni Valles, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Maria del Mar Piqueras, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Paz Escobar, Nurse
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Antonia Moreno, Nurse
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Montserrat Català, Nurse
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Anna Maria Ramirez, Nurse
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Maria Queralt Capdevila, Nurse
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Merce Botinas, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Lilia Villagrassa, Nurse
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Josep Maria Segura, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Maria del Mar Ballester, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Gustavo Losada, Physician
role: STUDY_CHAIR
affiliation: Catalan Institute of Health
name: Maria Teresa Maudos, Physician
role: STUDY_CHAIR
References:
citation: Casajuana J, Iglesias B, Fabregas M, Fina F, Valles JA, Aragones R, Benitez M, Zabaleta E. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial. BMC Blood Disord. 2008 May 29;8:1. doi: 10.1186/1471-2326-8-1.