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

Sponsor
Guangzhou Blood Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05319951
Collaborator
(none)
5,490
Enrollment
1
Location
3
Arms
16.3
Anticipated Duration (Months)
336.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Rehydration Salts power (iii)
  • Dietary Supplement: water with white granulated sugar
  • Dietary Supplement: water
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
5490 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
Actual Study Start Date :
Jan 20, 2021
Actual Primary Completion Date :
Nov 26, 2021
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. vasovagal reaction rate [1-3days]

      vasovagal reaction rate in three groups

    Secondary Outcome Measures

    1. rate of willingness to donate blood again [3days]

      rate of willingness to donate blood again in three groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

    -

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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Blood Center Guangzhou Guangdong China 510095

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangzhou Blood Center
    ClinicalTrials.gov Identifier:
    NCT05319951
    Other Study ID Numbers:
    • Different liquids intake
    First Posted:
    Apr 11, 2022
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Syncope, Vasovagal

    Study Results

    No Results Posted as of Apr 11, 2022