Status:
COMPLETED
Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy
Lead Sponsor:
Catalan Institute of Health
Conditions:
Influenza
Eligibility:
All Genders
18-95 years
Phase:
PHASE4
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 recom...
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 cont...
Eligibility Criteria
Inclusion
- Patients with oral anticoagulation therapy
- Patients who agree to be vaccinated
- Patients who agree to participate in the study
- Patients older than 18
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00137579
Start Date
September 1 2003
End Date
May 1 2004
Last Update
December 13 2005
Active Locations (4)
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1
Raval Nord
Barcelona, Barcelona, Spain, 08001
2
Raval Sud
Barcelona, Barcelona, Spain, 08001
3
Gotic
Barcelona, Barcelona, Spain, 08002
4
Casc Antic
Barcelona, Barcelona, Spain, 08003