Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy
December 12, 2005 updated by: Catalan Institute of Health
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
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment
216
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08001
- Raval Nord
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Barcelona, Spain, 08001
- Raval Sud
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Barcelona, Spain, 08002
- Gotic
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Barcelona, Spain, 08003
- Casc Antic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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local pain (scores greater than 3 in the analogic visual scale of pain)
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microbiologically diagnosed flu (yes/no)
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International Normalized Ratio (INR) to check the interaction between the vaccine and the oral anticoagulation therapy
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Secondary Outcome Measures
Outcome Measure |
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increase of the arm perimeter greater than 1 cm
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local elemental skin lesions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Josep Casajuana, Physician, Catalan Institute of Health
- Study Chair: Elvira Givert, Nurse, Catalan Institute of Health
- Study Chair: Josep Franch, Physician, Catalan Institute of Health
- Study Chair: Clara Sala, Nurse, Catalan Institute of Health
- Study Chair: Miriam Aballi, Physician, Catalan Institute of Health
- Study Chair: Begoña Iglesias, Physician, Catalan Institute of Health
- Study Chair: Joan Antoni Valles, Physician, Catalan Institute of Health
- Study Chair: Maria del Mar Piqueras, Physician, Catalan Institute of Health
- Study Chair: Paz Escobar, Nurse, Catalan Institute of Health
- Study Chair: Antonia Moreno, Nurse, Catalan Institute of Health
- Study Chair: Montserrat Català, Nurse, Catalan Institute of Health
- Study Chair: Anna Maria Ramirez, Nurse, Catalan Institute of Health
- Study Chair: Maria Queralt Capdevila, Nurse, Catalan Institute of Health
- Study Chair: Merce Botinas, Physician, Catalan Institute of Health
- Study Chair: Lilia Villagrassa, Nurse, Catalan Institute of Health
- Study Chair: Josep Maria Segura, Physician, Catalan Institute of Health
- Study Chair: Maria del Mar Ballester, Physician, Catalan Institute of Health
- Study Chair: Gustavo Losada, Physician, Catalan Institute of Health
- Study Chair: Maria Teresa Maudos, Physician, Catalan Institute of Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion
December 7, 2022
Study Completion
May 1, 2004
Study Registration Dates
First Submitted
August 29, 2005
First Submitted That Met QC Criteria
August 29, 2005
First Posted (Estimate)
August 30, 2005
Study Record Updates
Last Update Posted (Estimate)
December 13, 2005
Last Update Submitted That Met QC Criteria
December 12, 2005
Last Verified
January 1, 2003
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SINGRIP03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.