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FaintingEVASIONNCT02075099

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

A study testing tensing exercises and No tensing exercises in people with Fainting and Presyncope, run by Etablissement Français du Sang at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 71 yearsHealthy volunteers can take part
Conditions the study is for
Fainting, Presyncope, Syncopal Episode
What is being tested?
tensing exercises and No tensing exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,825 participants
Where
2 sitesFrance
Study dates
Jan 2014to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 71 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

France2 sites

  • EFS Grenoble

    Grenoble, 38000

  • EFS Lyon

    Lyon, 69000

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
tensing exercises, No tensing exercises
Keywords
whole blood donation, donation water drink, isotonic drink, presyncopal and syncopal reactions
Medical subject headings
Syncope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tensing exercisesOther

    Donors will do tensing exercises during blood donation

  • No tensing exercisesOther

    Donors will not do tensing exercises during blood donation - control arm

Study groups in NCT02075099
Study groupRoleWhat they receive
Isotonic drinkExperimentalPredonation 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")
Receives: Other: tensing exercises; Other: No tensing exercises
mineral waterExperimentalPredonation 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")
Receives: Other: tensing exercises; Other: No tensing exercises
AdvicesActive comparatorAdvices 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")
Receives: Other: tensing exercises; Other: No tensing exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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

    Measured: At the time of inclusion and at 48 hours after the blood donation

Secondary outcomes (9)

  1. daily activities

    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).

    Measured: 48 hours after the blood donation

  2. presyncopal and syncopal reactions of all donors

    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.

    Measured: inclusion and 48 hours after the blood donation

  3. presyncopal and syncopal reactions in the population of young donors (in schools)

    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.

    Measured: 48 hours after the blood donation

  4. presyncopal or syncopal reactions influence on subsequent 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)

    Measured: year which follows the blood donation

  5. Recurrence of presyncopal or syncopal reactions

    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

    Measured: year which follows the blood donation

  6. Explanatory variables of presyncopal and syncopal reactions

    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.

    Measured: 7 days after last donor inclusion

  7. subgroup analysis on collection unit characteristics

    subgroup analyses of the primary and secondary endpoints according to the characteristics of the collection unit used in the stratification of randomization of donors.

    Measured: 7 days after last donor inclusion

  8. medium term impact of the donation

    Main criterion and secondary criteria assessed at day 7 by phone call to the donor

    Measured: 7 days after the blood donation

  9. Restless legs syndrome

    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.

    Measured: months before the blood donation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJul 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
4,825 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02075099
Sponsor's protocol ID
DCIC 13 53
Acronym
EVASION
Status last verified
Feb 2015
First submitted
14 Feb 2014
Last updated
11 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • France CR, France JL, Kowalsky JM, Ellis GD, Copley DM, Geneser A, Frame-Brown T, Venable G, Graham D, Shipley P, Menitove JE. Assessment of donor fear enhances prediction of presyncopal symptoms among volunteer blood donors. Transfusion. 2012 Feb;52(2):375-80. doi: 10.1111/j.1537-2995.2011.03294.x. Epub 2011 Aug 16.

    PubMed 21848969

  • Eder AF, Hillyer CD, Dy BA, Notari EP 4th, Benjamin RJ. Adverse reactions to allogeneic whole blood donation by 16- and 17-year-olds. JAMA. 2008 May 21;299(19):2279-86. doi: 10.1001/jama.299.19.2279.

    PubMed 18492969

  • P. Tomasulo, M. Bravo et H. Kamel : Time course of vasovagal syncope with whole blood donation. ISBT Science Series, 2010 ; 5 : 52 - 58

  • Wieling W, France CR, van Dijk N, Kamel H, Thijs RD, Tomasulo P. Physiologic strategies to prevent fainting responses during or after whole blood donation. Transfusion. 2011 Dec;51(12):2727-38. doi: 10.1111/j.1537-2995.2011.03202.x. Epub 2011 Jun 3.

    PubMed 21645008

  • Kowalsky JM, France JL, Wissel ME, France CR. Effect of applied muscle tension on cerebral oxygenation in female blood donors. Transfusion. 2011 Aug;51(8):1802-8. doi: 10.1111/j.1537-2995.2011.03075.x. Epub 2011 Mar 7.

    PubMed 21382044

  • Eder AF. Improving safety for young blood donors. Transfus Med Rev. 2012 Jan;26(1):14-26. doi: 10.1016/j.tmrv.2011.07.008. Epub 2011 Aug 26.

    PubMed 21872427

  • Eder AF. Current efforts to reduce the risk of syncope among young blood donors. Curr Opin Hematol. 2012 Nov;19(6):480-5. doi: 10.1097/MOH.0b013e328358b15c.

    PubMed 22954724

  • van den Berg K, Lam J, Bruhn R, Custer B, Murphy EL. Water administration and the risk of syncope and presyncope during blood donation: a randomized clinical trial. Transfusion. 2012 Dec;52(12):2577-84. doi: 10.1111/j.1537-2995.2012.03631.x. Epub 2012 Apr 4.

    PubMed 22486209

  • Physiologie Humaine 3e édition Hervé Guénard, ed Pradel. Rein : 307 - 313

  • Eder AF, Notari EP 4th, Dodd RY. Do reactions after whole blood donation predict syncope on return donation? Transfusion. 2012 Dec;52(12):2570-6. doi: 10.1111/j.1537-2995.2012.03666.x. Epub 2012 Apr 27.

    PubMed 22536827

  • Eder A. Evidence-based selection criteria to protect blood donors. J Clin Apher. 2010;25(6):331-7. doi: 10.1002/jca.20257. Epub 2010 Sep 7.

    PubMed 20824625

  • Eder AF, Dy BA, Kennedy JM, Notari Iv EP, Strupp A, Wissel ME, Reddy R, Gibble J, Haimowitz MD, Newman BH, Chambers LA, Hillyer CD, Benjamin RJ. The American Red Cross donor hemovigilance program: complications of blood donation reported in 2006. Transfusion. 2008 Sep;48(9):1809-19. doi: 10.1111/j.1537-2995.2008.01811.x. Epub 2008 Jul 9.

    PubMed 18631167

  • Bravo M, Kamel H, Custer B, Tomasulo P. Factors associated with fainting: before, during and after whole blood donation. Vox Sang. 2011 Nov;101(4):303-12. doi: 10.1111/j.1423-0410.2011.01494.x. Epub 2011 May 3.

    PubMed 21535440

  • Carneiro-Proietti AB, Sabino EC, Sampaio D, Proietti FA, Goncalez TT, Oliveira CD, Ferreira JE, Liu J, Custer B, Schreiber GB, Murphy EL, Busch MP. Demographic profile of blood donors at three major Brazilian blood centers: results from the International REDS-II study, 2007 to 2008. Transfusion. 2010 Apr;50(4):918-25. doi: 10.1111/j.1537-2995.2009.02529.x. Epub 2009 Dec 10.

    PubMed 20003051

Questions about this trial

What is this clinical trial studying?

A study testing tensing exercises and No tensing exercises in people with Fainting and Presyncope, run by Etablissement Français du Sang at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02075099, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.

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