Status:
NOT_YET_RECRUITING
Prevention of Vasovagal Reactions in First-time Blood Donors Using a Combined PSYchological and Physiological Approach
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Vasovagal Reaction
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The prevention of vasovagal reactions (VVR) occurring during or after donation is a major issue for the French Blood Establishment (EFS), firstly to guarantee the safety of donors but also to retain t...
Eligibility Criteria
Inclusion
- M/F between 18 and 70 years old,
- A first-time donor who wishes to donate blood in Lyon, either at a fixed site or at a mobile unit,
- Declared fit to donate whole blood after the EFS pre-donation interview,
- Weight ≥ 50kg and height ≥ 135 cm,
- Available for telephone contact between to 5d +/- 2 days after donation,
- Having signed a written consent to participate in the study.
- Non-inclusion criteria:
- Known allergy to shellfish, and/or gluten, and/or milk, and/or soy,
- Incomprehension of the French language,
- First-time donor under protective measures (guardian, curator) or any other administrative measure,
- Not affiliated to the French social security system or any other equivalent system,
- Pregnant or breastfeeding woman,
- Subject participating in any other interventional or non-interventional research
Exclusion
- Withdrawal of consent
- First-time donor with anemia following routine hemoglobin testing
- First-time donor not reachable for telephone interview
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2026
Estimated Enrollment :
5320 Patients enrolled
Trial Details
Trial ID
NCT06014346
Start Date
October 10 2023
End Date
August 18 2026
Last Update
October 4 2023
Active Locations (1)
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1
French Blood Establishment (EFS)
Lyon, France, 69153