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

NCT02075099 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4825

Last updated 2015-02-11

No results posted yet for this study

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.

Conditions

  • Fainting
  • Presyncope
  • Syncopal Episode

Interventions

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

Sponsors & Collaborators

  • University Hospital, Grenoble

    collaborator OTHER
  • Etablissement Français du Sang

    lead OTHER

Principal Investigators

  • Chrystelle Morand, MD · EFS Rhone Alpes - Site Grenoble

  • Nicole Coudurier, MD · EFS LYON

  • Marie-Claude Bourboul, MD · EFS Rhone Alpes- Site Lyon

  • Debost Michèle, MD · EFS Rhone Alpes-site Lyon

  • Isabelle Michaud-Bauda, MD · EFS Rhone Alpes- site Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
71 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-07-31
Completion
2014-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02075099 on ClinicalTrials.gov