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

NCT02075099 | Completed

• 1 other identifier: DCIC 13 53
• Study Type: interventional
• Target: 4,825
• Locations: 1 country
• Sites: 2

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.

Conditions

Fainting; Presyncope; Syncopal Episode

Keywords

whole blood donation; donation water drink; isotonic drink; presyncopal and syncopal reactions

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (9)

• daily activities

  48 hours after the blood donation

• presyncopal and syncopal reactions of all donors

  inclusion and 48 hours after the blood donation

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

  48 hours after the blood donation

• presyncopal or syncopal reactions influence on subsequent blood donation

  year which follows the blood donation

• Recurrence of presyncopal or syncopal reactions

  year which follows the blood donation

Study Arms (3)

Isotonic drink

EXPERIMENTAL

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; Other: No tensing exercises

mineral water

EXPERIMENTAL

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; Other: No tensing exercises

Advices

ACTIVE COMPARATOR

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; Other: No tensing exercises

Interventions

tensing exercises OTHER

Donors will do tensing exercises during blood donation

Advices; Isotonic drink; mineral water

No tensing exercises OTHER

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

Advices; Isotonic drink; mineral water

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Whole blood donors , in fixed site or mobile collection
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Etablissement Français du Sang: lead
• University Hospital, Grenoble: collaborator

Study Sites (2)

EFS Grenoble

Grenoble, 38000, France

Location

EFS Lyon

Lyon, 69000, France

Location

Related Publications (40)

• 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

  BACKGROUND

• 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.

  PMID: 21848969 BACKGROUND

• 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.

  PMID: 18492969 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 21645008 BACKGROUND

• 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.

  PMID: 21382044 BACKGROUND

• 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.

  PMID: 21872427 BACKGROUND

• 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.

  PMID: 22954724 BACKGROUND

• 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.

  PMID: 22486209 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 22536827 BACKGROUND

• 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.

  PMID: 20824625 BACKGROUND

• 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.

  PMID: 18631167 BACKGROUND

• 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.

  PMID: 21535440 BACKGROUND

• 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.

  PMID: 20003051 BACKGROUND

• Trouern-Trend JJ, Cable RG, Badon SJ, Newman BH, Popovsky MA. A case-controlled multicenter study of vasovagal reactions in blood donors: influence of sex, age, donation status, weight, blood pressure, and pulse. Transfusion. 1999 Mar;39(3):316-20. doi: 10.1046/j.1537-2995.1999.39399219291.x.

  PMID: 10204597 BACKGROUND

• Wiltbank TB, Giordano GF, Kamel H, Tomasulo P, Custer B. Faint and prefaint reactions in whole-blood donors: an analysis of predonation measurements and their predictive value. Transfusion. 2008 Sep;48(9):1799-808. doi: 10.1111/j.1537-2995.2008.01745.x. Epub 2008 May 14.

  PMID: 18482188 BACKGROUND

• Eder AF, Dy BA, Kennedy JM, Perez J, Demaris P, Procaccio A, Benjamin RJ. Improved safety for young whole blood donors with new selection criteria for total estimated blood volume. Transfusion. 2011 Jul;51(7):1522-31. doi: 10.1111/j.1537-2995.2011.03143.x. Epub 2011 Apr 29.

  PMID: 21534981 BACKGROUND

• Newman B, Tommolino E, Andreozzi C, Joychan S, Pocedic J, Heringhausen J. The effect of a 473-mL (16-oz) water drink on vasovagal donor reaction rates in high-school students. Transfusion. 2007 Aug;47(8):1524-33. doi: 10.1111/j.1537-2995.2007.01293.x.

  PMID: 17655598 BACKGROUND

• Ando S, Kawamura N, Matsumoto M, Dan E, Takeshita A, Murakami K, Kashiwagi S, Kiyokawa H. Simple standing test predicts and water ingestion prevents vasovagal reaction in the high-risk blood donors. Transfusion. 2009 Aug;49(8):1630-6. doi: 10.1111/j.1537-2995.2009.02189.x.

  PMID: 19413739 BACKGROUND

• France CR, Ditto B, Wissel ME, France JL, Dickert T, Rader A, Sinclair K, McGlone S, Trost Z, Matson E. Predonation hydration and applied muscle tension combine to reduce presyncopal reactions to blood donation. Transfusion. 2010 Jun;50(6):1257-64. doi: 10.1111/j.1537-2995.2009.02574.x. Epub 2010 Jan 22.

  PMID: 20113455 BACKGROUND

• Tomasulo P, Kamel H, Bravo M, James RC, Custer B. Interventions to reduce the vasovagal reaction rate in young whole blood donors. Transfusion. 2011 Jul;51(7):1511-21. doi: 10.1111/j.1537-2995.2011.03074.x. Epub 2011 Mar 7.

  PMID: 21382043 BACKGROUND

• Scott EM, Greenwood JP, Stoker JB, Gilbey SG, Mary DA. Water drinking and sympathetic activation. Lancet. 2000 Dec 9;356(9246):2013. doi: 10.1016/S0140-6736(05)72987-1. No abstract available.

  PMID: 11130550 BACKGROUND

• A. F. Eder : can we improve safety for young blood donors ?. ISBT Science Series 2012;7:226-229

  BACKGROUND

• Custer B, Rios JA, Schlumpf K, Kakaiya RM, Gottschall JL, Wright DJ; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Adverse reactions and other factors that impact subsequent blood donation visits. Transfusion. 2012 Jan;52(1):118-26. doi: 10.1111/j.1537-2995.2011.03216.x. Epub 2011 Jun 17.

  PMID: 21682732 BACKGROUND

• France CR, France JL, Wissel ME, Ditto B, Dickert T, Himawan LK. Donor anxiety, needle pain, and syncopal reactions combine to determine retention: a path analysis of two-year donor return data. Transfusion. 2013 Sep;53(9):1992-2000. doi: 10.1111/trf.12069. Epub 2013 Jan 11.

  PMID: 23305267 BACKGROUND

• France CR, France JL, Himawan LK, Stephens KY, Frame-Brown TA, Venable GA, Menitove JE. How afraid are you of having blood drawn from your arm? A simple fear question predicts vasovagal reactions without causing them among high school donors. Transfusion. 2013 Feb;53(2):315-21. doi: 10.1111/j.1537-2995.2012.03726.x. Epub 2012 Jun 7.

  PMID: 22670781 BACKGROUND

• Veldhuizen I, Atsma F, van Dongen A, de Kort W. Adverse reactions, psychological factors, and their effect on donor retention in men and women. Transfusion. 2012 Sep;52(9):1871-9. doi: 10.1111/j.1537-2995.2011.03551.x. Epub 2012 Feb 10.

  PMID: 22321030 BACKGROUND

• Ditto B, France CR, Albert M, Byrne N, Smyth-Laporte J. Effects of applied muscle tension on the likelihood of blood donor return. Transfusion. 2009 May;49(5):858-62. doi: 10.1111/j.1537-2995.2008.02067.x. Epub 2009 Jan 21.

  PMID: 19175551 BACKGROUND

• Kamel H, Tomasulo P, Bravo M, Wiltbank T, Cusick R, James RC, Custer B. Delayed adverse reactions to blood donation. Transfusion. 2010 Mar;50(3):556-65. doi: 10.1111/j.1537-2995.2009.02397.x. Epub 2009 Oct 5.

  PMID: 19804573 BACKGROUND

• Ditto B, France CR, Holly C. Applied tension may help retain donors who are ambivalent about needles. Vox Sang. 2010 Apr;98(3 Pt 1):e225-30. doi: 10.1111/j.1423-0410.2009.01273.x.

  PMID: 20432513 BACKGROUND

• Masser B. Experienced donors, adverse events, and retention. Transfusion. 2012 Sep;52(9):1844-8. doi: 10.1111/j.1537-2995.2012.03829.x. No abstract available.

  PMID: 22946968 BACKGROUND

• Sinclair KS, Campbell TS, Carey PM, Langevin E, Bowser B, France CR. An adapted postdonation motivational interview enhances blood donor retention. Transfusion. 2010 Aug;50(8):1778-86. doi: 10.1111/j.1537-2995.2010.02618.x. Epub 2010 Apr 23.

  PMID: 20456674 BACKGROUND

• May M, Jordan J. The osmopressor response to water drinking. Am J Physiol Regul Integr Comp Physiol. 2011 Jan;300(1):R40-6. doi: 10.1152/ajpregu.00544.2010. Epub 2010 Nov 3.

  PMID: 21048076 BACKGROUND

• Schroeder C, Bush VE, Norcliffe LJ, Luft FC, Tank J, Jordan J, Hainsworth R. Water drinking acutely improves orthostatic tolerance in healthy subjects. Circulation. 2002 Nov 26;106(22):2806-11. doi: 10.1161/01.cir.0000038921.64575.d0.

  PMID: 12451007 BACKGROUND

• Endo Y, Yamauchi K, Tsutsui Y, Ishihara Z, Yamazaki F, Sagawa S, Shiraki K. Changes in blood pressure and muscle sympathetic nerve activity during water drinking in humans. Jpn J Physiol. 2002 Oct;52(5):421-7. doi: 10.2170/jjphysiol.52.421.

  PMID: 12533246 BACKGROUND

• 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.

  PMID: 15379740 BACKGROUND

• 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.

  PMID: 23286515 BACKGROUND

• 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.

  PMID: 16199481 BACKGROUND

• 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.

  PMID: 17714419 BACKGROUND

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: March 3, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 11, 2015

Record last verified: 2015-02

Locations

FR (2)