Evaluation of the Efficiency of Hydration by Isotonic Solution in the Prevent of the Fainting Whole Blood Donors
NCT ID: NCT02075099
Last Updated: 2015-02-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
4825 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-01-31
Study Completion Date
2014-08-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Fainting
Presyncope
Syncopal Episode
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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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")
Group Type
EXPERIMENTAL
tensing exercises
Intervention Type
OTHER
Donors will do tensing exercises during blood donation
No tensing exercises
Intervention Type
OTHER
Donors will not do tensing exercises during blood donation - control arm
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")
Group Type
EXPERIMENTAL
tensing exercises
Intervention Type
OTHER
Donors will do tensing exercises during blood donation
No tensing exercises
Intervention Type
OTHER
Donors will not do tensing exercises during blood donation - control arm
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")
Group Type
ACTIVE_COMPARATOR
tensing exercises
Intervention Type
OTHER
Donors will do tensing exercises during blood donation
No tensing exercises
Intervention Type
OTHER
Donors will not do tensing exercises during blood donation - control arm
Interventions
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tensing exercises
Donors will do tensing exercises during blood donation
Intervention Type
OTHER
No tensing exercises
Donors will not do tensing exercises during blood donation - control arm
Intervention Type
OTHER
Eligibility Criteria
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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
* 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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
71 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University Hospital, Grenoble
OTHER
Sponsor Role
collaborator
Etablissement Français du Sang
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Chrystelle Morand, MD
Role: PRINCIPAL_INVESTIGATOR
EFS Rhone Alpes - Site Grenoble
Nicole Coudurier, MD
Role: PRINCIPAL_INVESTIGATOR
EFS LYON
Marie-Claude Bourboul, MD
Role: PRINCIPAL_INVESTIGATOR
EFS Rhone Alpes- Site Lyon
Debost Michèle, MD
Role: PRINCIPAL_INVESTIGATOR
EFS Rhone Alpes-site Lyon
Isabelle Michaud-Bauda, MD
Role: PRINCIPAL_INVESTIGATOR
EFS Rhone Alpes- site Grenoble
Locations
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EFS Grenoble
Grenoble, , France
Site Status
EFS Lyon
Lyon, , France
Site Status
Countries
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France
References
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V. Candas, B. Bothorel : Hydratation, travail et chaleur. , INRS CDU 613-3 Fiche d'hygiène de vie au travail, Cahier de notes documentaires n° 135, 2ème trimestre 1989 : 241 - 245
Reference Type
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Physiologie Humaine 3e édition Hervé Guénard, ed Pradel. Rein : 307 - 313
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Mathias CJ, Young TM. Water drinking in the management of orthostatic intolerance due to orthostatic hypotension, vasovagal syncope and the postural tachycardia syndrome. Eur J Neurol. 2004 Sep;11(9):613-9. doi: 10.1111/j.1468-1331.2004.00840.x.
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Moreno IL, Pastre CM, Ferreira C, de Abreu LC, Valenti VE, Vanderlei LC. Effects of an isotonic beverage on autonomic regulation during and after exercise. J Int Soc Sports Nutr. 2013 Jan 4;10(1):2. doi: 10.1186/1550-2783-10-2.
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Charkoudian N, Eisenach JH, Joyner MJ, Roberts SK, Wick DE. Interactions of plasma osmolality with arterial and central venous pressures in control of sympathetic activity and heart rate in humans. Am J Physiol Heart Circ Physiol. 2005 Dec;289(6):H2456-60. doi: 10.1152/ajpheart.00601.2005. Epub 2005 Sep 30.
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Ditto B, France CR, Albert M, Byrne N. Dismantling applied tension: mechanisms of a treatment to reduce blood donation-related symptoms. Transfusion. 2007 Dec;47(12):2217-22. doi: 10.1111/j.1537-2995.2007.01449.x. Epub 2007 Aug 21.
Reference Type
BACKGROUND
Other Identifiers
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DCIC 13 53
Identifier Type: -
Identifier Source: org_study_id
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