Evaluation of the Efficiency of Hydration by Isotonic Solution in the Prevent of the Fainting Whole Blood Donors
NCT02075099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4825
Last updated 2015-02-11
Summary
Blood donation is a generous act carried out by healthy male and female volunteer donors. The safety of blood donation in France is based on rigorous well documented biological and medical criteria, in particular concerning the volume of blood to be taken. While whole blood donation is very safe, some donors experience faintness during or after donation. Any injury resulting from a fall increases its seriousness, especially when it happens outside the donation site.
According to various studies, adverse reactions are experienced by between 0.28% and 2.72% of all donors and occur in all categories (sex and age).
A retrospective evaluation of the frequency of faintness incidents on during whole blood donation over 2012 in the Rhone Alpes' region of France shows a frequency ranging from 1.05% in mobile donation units in towns to 4.24% in donation units in high schools, with no reporting of delayed incidents of faintness by this donor population.
Conditions
- Fainting
- Presyncope
- Syncopal Episode
Interventions
- OTHER
-
tensing exercises
Donors will do tensing exercises during blood donation
- OTHER
-
No tensing exercises
Donors will not do tensing exercises during blood donation - control arm
Sponsors & Collaborators
-
University Hospital, Grenoble
collaborator OTHER -
Etablissement Français du Sang
lead OTHER
Principal Investigators
-
Chrystelle Morand, MD · EFS Rhone Alpes - Site Grenoble
-
Nicole Coudurier, MD · EFS LYON
-
Marie-Claude Bourboul, MD · EFS Rhone Alpes- Site Lyon
-
Debost Michèle, MD · EFS Rhone Alpes-site Lyon
-
Isabelle Michaud-Bauda, MD · EFS Rhone Alpes- site Grenoble
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 71 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-08-31
Countries
- France
Study Locations
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