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

Presyncope Clinical Trial

— EVASION  

Official title:

Evaluation of the Efficiency of a Hydration by Isotonic Solution With or Without Muscular Exercise of the Fainting Whole Blood Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075099
• Other study ID #: DCIC 13 53
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: February 10, 2015
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Etablissement Français du Sang
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4825
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 71 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fainting
• Presyncope
• Syncopal Episode
• Syncope

Intervention

Other:
• tensing exercises
Donors will do tensing exercises during blood donation
• No tensing exercises
Donors will not do tensing exercises during blood donation - control arm

Locations

Country	Name	City	State
France	EFS Grenoble	Grenoble
France	EFS Lyon	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Etablissement Français du Sang	University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (40)

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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. — View Citation

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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. — View Citation

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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. — View 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. — View 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. — View 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. — View Citation

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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. — View Citation

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	48 hours after the blood donation	No
Secondary	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.	inclusion and 48 hours after the blood donation	No
Secondary	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.	48 hours after the blood donation	No
Secondary	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)	year which follows the blood donation	No
Secondary	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	year which follows the blood donation	No
Secondary	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.	7 days after last donor inclusion	No
Secondary	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.	7 days after last donor inclusion	No
Secondary	medium term impact of the donation	Main criterion and secondary criteria assessed at day 7 by phone call to the donor	7 days after the blood donation	No
Secondary	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.	months before the blood donation	No