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

Etablissement Français du Sang

Status: Completed

Conditions: Syncopal Episode; Presyncope; Fainting

Treatments: Other: tensing exercises; Other: No tensing exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT02075099

DCIC 13 53

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,825 patients

Sex: All

Ages: 18 to 71 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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4,825 participants in 3 patient groups

Isotonic drink

Experimental group

Description:

Predonation 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")

Treatment:

Other: No tensing exercises

Other: tensing exercises

mineral water

Experimental group

Description:

Predonation 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")

Treatment:

Other: No tensing exercises

Other: tensing exercises

Advices

Active Comparator group

Description:

Advices 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")

Treatment:

Other: No tensing exercises

Other: tensing exercises