Clinical trial NCT02075099: Evaluation of the Efficiency of Hydration by Isotonic Solution in the Prevent of the Fainting Whole Blood Donors
Official title: Evaluation of the Efficiency of a Hydration by Isotonic Solution With or Without Muscular Exercise of the Fainting Whole Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fainting
Presyncope
Syncopal Episode
Keywords: whole blood donation
donation water drink
isotonic drink
presyncopal and syncopal reactions
Lead sponsor: Etablissement Français du Sang
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
First posted: 2014-03-03
Enrollment: 4825
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: At the time of inclusion and at 48 hours after the blood donation
Secondary outcomes:
measure: daily activities
timeFrame: 48 hours after the blood donation
measure: presyncopal and syncopal reactions of all donors
timeFrame: inclusion and 48 hours after the blood donation
measure: presyncopal and syncopal reactions in the population of young donors (in schools)
timeFrame: 48 hours after the blood donation
measure: presyncopal or syncopal reactions influence on subsequent blood donation
timeFrame: year which follows the blood donation
measure: Recurrence of presyncopal or syncopal reactions
timeFrame: year which follows the blood donation
measure: Explanatory variables of presyncopal and syncopal reactions
timeFrame: 7 days after last donor inclusion
measure: subgroup analysis on collection unit characteristics
timeFrame: 7 days after last donor inclusion
measure: medium term impact of the donation
timeFrame: 7 days after the blood donation
measure: Restless legs syndrome
timeFrame: months before the blood donation
Other outcomes:
Locations:
city: Grenoble
country: France
facility: EFS Grenoble
city: Lyon
country: France
facility: EFS Lyon
Study officials:
affiliation: EFS Rhone Alpes - Site Grenoble
name: Chrystelle Morand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EFS LYON
name: Nicole Coudurier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EFS Rhone Alpes- Site Lyon
name: Marie-Claude Bourboul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EFS Rhone Alpes-site Lyon
name: Debost Michèle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EFS Rhone Alpes- site Grenoble
name: Isabelle Michaud-Bauda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: P. Tomasulo, M. Bravo et H. Kamel : Time course of vasovagal syncope with whole blood donation. ISBT Science Series, 2010 ; 5 : 52 - 58
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Physiologie Humaine 3e édition Hervé Guénard, ed Pradel. Rein : 307 - 313
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: A. F. Eder : can we improve safety for young blood donors ?. ISBT Science Series 2012;7:226-229
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.