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

Sponsor

Etablissement Français du Sang (Other)

Overall Status

Completed

CT.gov ID

NCT02075099

Collaborator

University Hospital, Grenoble (Other)

4,825

Enrollment

Locations

Arms

Duration (Months)

2412.5

Patients Per Site

346.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Fainting Presyncope Syncopal Episode	Other: tensing exercises Other: No tensing exercises	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4825 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Isotonic drink 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")	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
Experimental: mineral water 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")	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
Active Comparator: Advices 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")	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

Arm

Intervention/Treatment

Experimental: Isotonic drink

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")

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

Experimental: mineral water

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")

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

Active Comparator: Advices

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")

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

Outcome Measures

Primary Outcome Measures

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 [At the time of inclusion and at 48 hours after the blood donation]
Symptoms of presyncopal reactions (blurring of vision, insensitivity to ambient noises, generalized weakness, paleness, nausea) and syncopal reactions that required the donor to be placed in the 'Trendelenburg' position Presyncopal and syncopal symptoms requiring interruption of the blood donation Vomiting Unconsciousness with interruption of blood donation, with no other consequences and no specific treatment. Convulsions Leak of urine Unconsciousness with interruption of blood donation with no other consequences, but with medical treatment by an oral route. Unconsciousness with interruption of blood donation with no other consequences, but requiring a perfusion or intravenous treatment. Unconsciousness immediately post donation with or without consequences Presyncopal and syncopal reactions with or without consequences within the 48 hours after the blood donation Angina, infarct Death

Secondary Outcome Measures

daily activities [48 hours after the blood donation]
Evaluation of the impact of whole blood donation assess by : Modification of daily habits. Fatigue assessment scale for healthy subjects. Unusual fatigue depending on the type of proposed prevention (drinks and exercises).
presyncopal and syncopal reactions of all donors [inclusion and 48 hours after the blood donation]
This concerns presyncopal and syncopal reactions that required the donor to lie down in the Trendelenburg position and any further intervention. We will compare the occurrence of presyncopal and syncopal reactions during the blood donation, or immediately post-donation, while still in the blood donation center, and within 48 hours following blood donation. We will analysed separate from that of the main criterion in three periods: during the donation, immediate post donation, late post donation.
presyncopal and syncopal reactions in the population of young donors (in schools) [48 hours after the blood donation]
Main criteria analyzed in the sub-population of blood donation at schools Evaluate the rate of presyncopal and syncopal reactions after the donation, but within 48 hours, in the population of young donors attending blood collection centers in schools.
presyncopal or syncopal reactions influence on subsequent blood donation [year which follows the blood donation]
Evaluate the influence of the occurrence of presyncopal or syncopal reactions on subsequent blood donation or not. Renewal of blood donation within one year (from the EFS database)
Recurrence of presyncopal or syncopal reactions [year which follows the blood donation]
Presyncopal and syncopal reactions during a following blood donation made within one year and listed in the EFS donor safety database Evaluate whether the occurrence of presyncopal or syncopal reactions is a predictor of recurrence during the next blood donation
Explanatory variables of presyncopal and syncopal reactions [7 days after last donor inclusion]
Variables linked to the presyncopal and syncopal reactions as defined by the main criterion Explanatory variables: the characteristics of the donor (age, sex, number of previous blood donations), the circumstances of the blood donation (work or effort before the blood donation, the time of day of the blood donation, the quality of the post donation snack (sweet/salty) etc. and the characteristics of the blood donation unit/center (fixed/mobile, school/company/town, room/ mobile blood donation unit, size of the town, place of blood donation.
subgroup analysis on collection unit characteristics [7 days after last donor inclusion]
subgroup analyses of the primary and secondary endpoints according to the characteristics of the collection unit used in the stratification of randomization of donors.
medium term impact of the donation [7 days after the blood donation]
Main criterion and secondary criteria assessed at day 7 by phone call to the donor
Restless legs syndrome [months before the blood donation]
during phone call to the donor at day 7, questions will be asked about possible or probable RLS (Restless Legs Syndrome). Classification of Bryan R. Spencer (Transfusion August 2013) will be used.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 71 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	EFS Grenoble	Grenoble		France	38000
2	EFS Lyon	Lyon		France	69000

Sponsors and Collaborators

Etablissement Français du Sang
University Hospital, Grenoble

Investigators

Principal Investigator: Chrystelle Morand, MD, EFS Rhone Alpes - Site Grenoble
Principal Investigator: Nicole Coudurier, MD, EFS LYON
Principal Investigator: Marie-Claude Bourboul, MD, EFS Rhone Alpes- Site Lyon
Principal Investigator: Debost Michèle, MD, EFS Rhone Alpes-site Lyon
Principal Investigator: Isabelle Michaud-Bauda, MD, EFS Rhone Alpes- site Grenoble