Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy

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.

Conditions

• Influenza

Interventions

PROCEDURE

Influenza vaccine intramuscular administration route

Sponsors & Collaborators

• Catalan Institute of Health

  lead OTHER_GOV

Principal Investigators

• Josep Casajuana, Physician · Catalan Institute of Health

• Elvira Givert, Nurse · Catalan Institute of Health

• Josep Franch, Physician · Catalan Institute of Health

• Clara Sala, Nurse · Catalan Institute of Health

• Miriam Aballi, Physician · Catalan Institute of Health

• Begoña Iglesias, Physician · Catalan Institute of Health

• Joan Antoni Valles, Physician · Catalan Institute of Health

• Maria del Mar Piqueras, Physician · Catalan Institute of Health

• Paz Escobar, Nurse · Catalan Institute of Health

• Antonia Moreno, Nurse · Catalan Institute of Health

• Montserrat Català, Nurse · Catalan Institute of Health

• Anna Maria Ramirez, Nurse · Catalan Institute of Health

• Maria Queralt Capdevila, Nurse · Catalan Institute of Health

• Merce Botinas, Physician · Catalan Institute of Health

• Lilia Villagrassa, Nurse · Catalan Institute of Health

• Josep Maria Segura, Physician · Catalan Institute of Health

• Maria del Mar Ballester, Physician · Catalan Institute of Health

• Gustavo Losada, Physician · Catalan Institute of Health

• Maria Teresa Maudos, Physician · Catalan Institute of Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-09-30

Completion

2004-05-31

Countries

• Spain

Study Locations