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
Sponsor study identifier
interventional
216
1 country
4
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
August 29, 2005
Actual (reported)August 30, 2005
Actual (reported)local pain (scores greater than 3 in the analogic visual scale of pain)
microbiologically diagnosed flu (yes/no)
International Normalized Ratio (INR) to check the interaction between the vaccine and the oral anticoagulation therapy
increase of the arm perimeter greater than 1 cm
local elemental skin lesions
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Raval Nord
Barcelona, Barcelona, 08001, Spain
Raval Sud
Barcelona, Barcelona, 08001, Spain
Gotic
Barcelona, Barcelona, 08002, Spain
Casc Antic
Barcelona, Barcelona, 08003, Spain
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.
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
First Submitted
August 29, 2005
First Posted
August 30, 2005
Study Start
September 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
May 2004
Date type not reportedComparison of Inactivated and Live, Attenuated Influenza Vaccine in Children 5-9 Years of Age-Year 3 Amendment
Contact the study team to confirm eligibility.
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
This date has not been verified as actual or estimated.
Last Updated
December 13, 2005
Record last verified: 2003-01
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Source: ClinicalTrials.gov.
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