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Fainting | Evaluation of the Efficiency of Hydration by Isotonic Solution in the Prevent of the Fainting Whole Blood Donors

Fainting research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - Whole blood donors , in fixed site or mobile collection - 18-year-old and less than 71 years - Donor with weight > in 50 kg and height> 135 cms - Whole Blood donors having had an interview with a doctor of the EFS and declared capable - Donors for phone contact in 7 days following the donation Exclusion Criteria: - Collection by an autonomous mobile blood collection unit (with independent management and sample storage) - Donor with an immobilization, even partial, of a lower limb. - Donor allergic to shellfish, gluten, milk or soya. - Donor under judicial protection or other administrative control.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Fainting

Presyncope

Syncopal Episode

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:tensing exercisesDonors will do tensing exercises during blood donation

Other:No tensing exercisesDonors will not do tensing exercises during blood donation - control arm

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Isotonic drinkPredonation hydratation with 500 ml of isotonic drink, to drinking in immediate predonation. (The half of included donors will do "tensing exercises" during the blood whole donation and the other half will do "no tensing exercises")

mineral waterPredonation hydratation with 500 ml of mineral water to drinking in immediate predonation whole blood. (The half of included donors will do "tensing exercises" during the blood whole donation and the other half will do "no tensing exercises")

AdvicesAdvices of drinking water or fruit juice glass(es) in immediate predonation whole blood. (The half of included donors will do "tensing exercises" during the blood whole donation and the other half will do "no tensing exercises")

Study Status

Completed

Start Date: January 2014

Completed Date: August 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Accumulated incidence of presyncopal and syncopal reactions during blood donation, while still at the blood donation whole and within 48 hours of the blood donation, that required the donor to be placed in a 'Trendelenburg' position

Secondary Outcome: daily activities

Study sponsors, principal investigator, and references

Principal Investigator: Chrystelle Morand, MD

Lead Sponsor: Etablissement Français du Sang

Collaborator: University Hospital, Grenoble

More information:https://clinicaltrials.gov/show/NCT02075099

V. Candas, B. Bothorel : Hydratation, travail et chaleur. , INRS CDU 613-3 Fiche d'hygiène de vie au travail, Cahier de notes documentaires n° 135, 2ème trimestre 1989 : 241 - 245

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