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

Presyncope Clinical Trial

Official title: Evaluation of the Efficiency of a Hydration by Isotonic Solution With or Without Muscular Exercise of the Fainting Whole Blood Donors

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fainting
• Presyncope
• Syncopal Episode
• Syncope

• NCT number: NCT02075099
• Study type: Interventional
• Source: Etablissement Français du Sang
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: August 2014