Evaluation of the Efficiency of Hydration by Isotonic Solution in the Prevent of the Fainting Whole Blood Donors
Condition: Fainting; Presyncope; Syncopal Episode
MeSH terms: Syncope
Study type: Interventional

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.
    

Detailed description: 
      Despite precautions including advice to donors to drink some water before blood donation,
      fainting events still occur. They can have an impact on the frequency of donation as well as
      on the blood donor's motivation and that in their close entourage. This impact should not be
      overlooked in the context of the increasing need for blood components and tighter budgets..

      In some other national health systems, the donor is given a drink shortly before giving blood
      and / or donors are advised to do lower-body muscle tensing exercises whilst giving blood.

      The present study has a factorial design and compares 3 arms for hydration criteria and 2
      arms for exercise criteria with cluster randomization (1 cluster = 1 blood donation unit).
      The randomization plan will be stratified according to the type of EFS donation unit (French
      Blood Donation service: Etablissement Français du Sang): Fixed/Mobile unit; and also on the
      location of the of mobile blood donation unit: in companies, towns or schools. In the latter,
      the blood donors have a potentially higher risk of presyncopal or syncopal reactions.

      3 arms:

        -  500mL of an isotonic drink to be drunk immediately before blood donation

        -  500mL of slightly mineralized water to be drunk immediately before blood donation

        -  Advice to drink one glass of fruit juice or water before blood donation In the 3 arms,
           the centralized randomization will balance the numbers of blood donations in which the
           donors will perform lower-body muscle tensing exercises , or not, during the blood
           donation.

      Main objective:

      To assess the impact of preventive measures, including rapid hydration with 500mL of an
      isotonic drink versus hydration with 500mL of water or simple advice to have a drink; and
      advice to perform lower-body muscle tensing exercises during the whole blood donation, on the
      prevention of presyncopal and syncopal reactions during blood donation and in the following
      48 hours.
    

Intervention name(s): tensing exercises; No tensing exercises
Intervention type(s): Other; Other
Intervention description(s): Donors will do tensing exercises during blood donation; Donors will not do tensing exercises during blood donation - control arm
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: whole blood donation; donation water drink; isotonic drink; presyncopal and syncopal reactions