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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine intramuscular administration route | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| increase of the arm perimeter greater than 1 cm | ||
| local elemental skin lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep Casajuana, Physician | Catalan Institute of Health | Principal Investigator |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raval Nord | Barcelona | Barcelona | 08001 | Spain | ||
| Raval Sud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18507871 | Derived | 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. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Catalan Institute of Health |
| Study Chair |
| Montserrat CatalĂ , 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 | Study Chair |
| Barcelona |
| Barcelona |
| 08001 |
| Spain |
| Gotic | Barcelona | Barcelona | 08002 | Spain |
| Casc Antic | Barcelona | Barcelona | 08003 | Spain |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |