We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00137579
First Posted: August 30, 2005
Last Update Posted: December 13, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catalan Institute of Health
  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
Intervention Model: Parallel Assignment
Masking: Single
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137579


Locations
Spain
Raval Nord
Barcelona, Spain, 08001
Raval Sud
Barcelona, Spain, 08001
Gotic
Barcelona, Spain, 08002
Casc Antic
Barcelona, Spain, 08003
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00137579     History of Changes
Other Study ID Numbers: SINGRIP03
First Submitted: August 29, 2005
First Posted: August 30, 2005
Last Update Posted: December 13, 2005
Last Verified: January 2003

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs