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

• Sponsor: Catalan Institute of Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00137579
• Collaborator: (none)
• Enrollment: 216
• Locations: 4
• Duration (Months): 8
• Patients Per Site: 54
• Patients Per Site Per Month: 6.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Influenza	Procedure: Influenza vaccine intramuscular administration route	Phase 4

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 Design

• Study Type: Interventional
• 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
• Study Start Date: Sep 1, 2003
• Study Completion Date: May 1, 2004

Outcome Measures

Primary Outcome Measures

1. local pain (scores greater than 3 in the analogic visual scale of pain) []

2. microbiologically diagnosed flu (yes/no) []

3. International Normalized Ratio (INR) to check the interaction between the vaccine and the oral anticoagulation therapy []

Secondary Outcome Measures

1. increase of the arm perimeter greater than 1 cm []

2. local elemental skin lesions []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Raval Nord	Barcelona		Spain	08001
2	Raval Sud	Barcelona		Spain	08001
3	Gotic	Barcelona		Spain	08002
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00137579
• Other Study ID Numbers: SINGRIP03
• First Posted: Aug 30, 2005
• Last Update Posted: Dec 13, 2005
• Last Verified: Jan 1, 2003

• Keywords provided by , ,: Influenza Vaccines; Acenocoumarol; Drug Administration Routes; Anticoagulants
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Dec 13, 2005