Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137579
Status:
COMPLETED
Last Update Posted:
2005-12-13
First Post:
2005-08-29
Brief Title:
Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy
Sponsor:
Catalan Institute of Health
Organization:
Catalan Institute of Health
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None