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

This study has been completed.
Sponsor:
Information provided by:
Catalan Institute of Health
ClinicalTrials.gov Identifier:
NCT00137579
First received: August 29, 2005
Last updated: December 12, 2005
Last verified: January 2003
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Procedure: Influenza vaccine intramuscular administration route
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Flu
U.S. FDA Resources

Further study details as provided by Catalan Institute of Health:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • increase of the arm perimeter greater than 1 cm
  • local elemental skin lesions

Estimated Enrollment: 216
Study Start Date: September 2003
Estimated Study Completion Date: May 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137579

Locations
Spain
Casc Antic
Barcelona, Spain, 08003
Raval Sud
Barcelona, Spain, 08001
Raval Nord
Barcelona, Spain, 08001
Gotic
Barcelona, Spain, 08002
Sponsors and Collaborators
Catalan Institute of Health
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00137579     History of Changes
Other Study ID Numbers: SINGRIP03
Study First Received: August 29, 2005
Last Updated: December 12, 2005
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Catalan Institute of Health:
Influenza Vaccines
Acenocoumarol
Drug Administration Routes
Anticoagulants

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013