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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2004-05-31

Brief Summary

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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

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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.

Conditions

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Influenza

Keywords

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Influenza Vaccines Acenocoumarol Drug Administration Routes Anticoagulants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Influenza vaccine intramuscular administration route

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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.

Reference Type DERIVED

PMID: 18507871 (View on PubMed)

Other Identifiers

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SINGRIP03

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Influenza vaccine intramuscular administration route

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Catalan Institute of Health

Principal Investigators

Josep Casajuana, Physician

Elvira Givert, Nurse

Josep Franch, Physician

Clara Sala, Nurse

Miriam Aballi, Physician

Begoña Iglesias, Physician

Joan Antoni Valles, Physician

Maria del Mar Piqueras, Physician

Paz Escobar, Nurse

Antonia Moreno, Nurse

Montserrat Català, Nurse

Anna Maria Ramirez, Nurse

Maria Queralt Capdevila, Nurse

Merce Botinas, Physician

Lilia Villagrassa, Nurse

Josep Maria Segura, Physician

Maria del Mar Ballester, Physician

Gustavo Losada, Physician

Maria Teresa Maudos, Physician

Locations

Raval Nord

Raval Sud

Gotic

Casc Antic

Countries

References

Other Identifiers

SINGRIP03