Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation

we compared the effect of 3 different kinds of liquids (water, Oral Rehydration Salt 3 and white granulated sugar water) intake in Vasovagal Reaction After Whole Blood Donation

Study Overview

• Status: Completed
• Conditions: Blood Donation
• Intervention / Treatment: Drug: Oral Rehydration Salts power (iii); Dietary supplement: water with white granulated sugar; Dietary supplement: water

Detailed Description

Vasovagal reaction is the most common type of blood donation reaction. The main cause of this reaction is the decrease of blood volume. Therefore, fluid supplement before blood donation has been proved to be effective in preventing the vagal reaction after blood donation. It was proved that isotonic (sugar & salt) drink intake before blood donation had a significant effect on reducing vasovagal reaction.

However, in 2002, WHO recommended the new reduced osmolarity rehydration formula with better taste. Oral Rehydration Salt 3 has been produced according to WHO formula with standard ingredient and easy to prepare. In addition, in Guangdong culture, sugar water is regarded as a tonic, more easily accepted. So, the aim of our study was to compare the effects of 500 ml water with Oral Rehydration Salt 3, white granulated sugar and conventional recommended water intake prior to blood donation on blood donation reaction after whole blood donation, in order to understand the effect of different liquid supplement on blood donation reaction and the willingness of blood donation again.

• Study Type: Interventional
• Enrollment (Actual): 6250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510095
      • Guangzhou Blood Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:All blood donors donated whole blood in Guangzhou Blood Center during study.

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Exclusion Criteria:Blood donors who were deferral by blood screening result and other situations.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oral Rehydration Salts Power (iii); Dissolve 2 packs of Oral Rehydration Salts Power (iii) (5.125g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.	Drug: Oral Rehydration Salts power (iii); Dissolve 2 packs of Oral Rehydration Salts Power (iii) (5.125g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.; Other Names: Sichuan Emeishan Pharmaceutical Co., Ltd. 20210402 5100621103491
EXPERIMENTAL: water with white granulated sugar; Dissolve 2 packs of Taikoo white granulated sugar (5g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.	Dietary supplement: water with white granulated sugar; Dissolve 2 packs of Taikoo white granulated sugar (5g/pack) in 500ml water and let the subjects drink it up in 20 minutes prior to donation.
PLACEBO_COMPARATOR: recommended water intake; Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.	Dietary supplement: water; Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vasovagal reaction rate	vasovagal reaction rate in three groups	1-3days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of willingness to donate blood again	rate of willingness to donate blood again in three groups	3days

Collaborators and Investigators

• Sponsor: Guangzhou Blood Center
• Investigators: Study Chair: Guiyun Xie, MPH, Guangzhou Blood Center; Principal Investigator: Jinyan Chen, MPH, Guangzhou Blood Center; Study Director: Shijie Li, Guangzhou Blood Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2021
• Primary Completion (ACTUAL): November 26, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (ACTUAL): April 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: Different liquids intake

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No