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

February 10, 2015 updated by: Etablissement Français du Sang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4825

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • EFS Grenoble
      • Lyon, France, 69000
        • EFS Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
At the time of inclusion and at 48 hours after the blood donation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily activities
Time Frame: 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).
48 hours after the blood donation
presyncopal and syncopal reactions of all donors
Time Frame: 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.
inclusion and 48 hours after the blood donation
presyncopal and syncopal reactions in the population of young donors (in schools)
Time Frame: 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.
48 hours after the blood donation
presyncopal or syncopal reactions influence on subsequent blood donation
Time Frame: 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)
year which follows the blood donation
Recurrence of presyncopal or syncopal reactions
Time Frame: 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
year which follows the blood donation
Explanatory variables of presyncopal and syncopal reactions
Time Frame: 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.
7 days after last donor inclusion
subgroup analysis on collection unit characteristics
Time Frame: 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.
7 days after last donor inclusion
medium term impact of the donation
Time Frame: 7 days after the blood donation
Main criterion and secondary criteria assessed at day 7 by phone call to the donor
7 days after the blood donation
Restless legs syndrome
Time Frame: 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.
months before the blood donation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etablissement Français du Sang

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 13 53

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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