Back to resultsEffect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
Primary Purpose
Blood Donation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Oral Rehydration Salts power (iii)
water with white granulated sugar
water
Sponsored by
About this trial
This is an interventional health services research trial for Blood Donation
Eligibility Criteria
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.
-
Sites / Locations
- Guangzhou Blood Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Oral Rehydration Salts Power (iii)
water with white granulated sugar
recommended water intake
Arm Description
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.
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.
Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.
Outcomes
Primary Outcome Measures
vasovagal reaction rate
vasovagal reaction rate in three groups
Secondary Outcome Measures
rate of willingness to donate blood again
rate of willingness to donate blood again in three groups
Full Information
NCT ID
NCT05319951
First Posted
December 1, 2020
Last Updated
September 30, 2022
Sponsor
Guangzhou Blood Center
1. Study Identification
Unique Protocol Identification Number
NCT05319951
Brief Title
Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
Official Title
Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
November 26, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Blood Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Donation
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Rehydration Salts Power (iii)
Arm Type
Experimental
Arm Description
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.
Arm Title
water with white granulated sugar
Arm Type
Experimental
Arm Description
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.
Arm Title
recommended water intake
Arm Type
Placebo Comparator
Arm Description
Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.
Intervention Type
Drug
Intervention Name(s)
Oral Rehydration Salts power (iii)
Other Intervention Name(s)
Sichuan Emeishan Pharmaceutical Co., Ltd. 20210402 5100621103491
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
water with white granulated sugar
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
water
Intervention Description
Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.
Primary Outcome Measure Information:
Title
vasovagal reaction rate
Description
vasovagal reaction rate in three groups
Time Frame
1-3days
Secondary Outcome Measure Information:
Title
rate of willingness to donate blood again
Description
rate of willingness to donate blood again in three groups
Time Frame
3days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guiyun Xie, MPH
Organizational Affiliation
Guangzhou Blood Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jinyan Chen, MPH
Organizational Affiliation
Guangzhou Blood Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shijie Li
Organizational Affiliation
Guangzhou Blood Center
Official's Role
Study Director
Facility Information:
Facility Name
Guangzhou Blood Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
12. IPD Sharing Statement
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Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
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