Blood DonationNCT05319951
Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
A study testing Oral Rehydration Salts power (iii), water with white granulated sugar and water in people with Blood Donation, run by Guangzhou Blood Center at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Blood Donation
- What is being tested?
- Oral Rehydration Salts power (iii), water with white granulated sugar and water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,250 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
-
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Blood Donation
- Being tested
- Oral Rehydration Salts power (iii), water with white granulated sugar, water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Rehydration Salts power (iii)Drug
Also called Sichuan Emeishan Pharmaceutical Co., Ltd. 20210402 5100621103491
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.
water with white granulated sugarDietary supplement
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.
waterDietary supplement
Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.
| Study group | Role | What they receive |
|---|---|---|
| Oral Rehydration Salts Power (iii) | Experimental | 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. Receives: Drug: Oral Rehydration Salts power (iii) |
| water with white granulated sugar | Experimental | 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. Receives: Dietary Supplement: water with white granulated sugar |
| recommended water intake | Placebo comparator | Recommend the subjects to drink up 500ml water in 20 minutes prior to donation. Receives: Dietary Supplement: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
vasovagal reaction rate
vasovagal reaction rate in three groups
Measured: 1-3days
Secondary outcomes (1)
rate of willingness to donate blood again
rate of willingness to donate blood again in three groups
Measured: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start20 Jan 2021
- Primary completion26 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Blood Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guiyun Xie, MPH, Study chair, Guangzhou Blood CenterJinyan Chen, MPH, Principal investigator, Guangzhou Blood CenterShijie Li, Study director, Guangzhou Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319951
- Sponsor's protocol ID
- Different liquids intake
- Status last verified
- Sep 2022
- First submitted
- 1 Dec 2020
- Last updated
- 3 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
- ClinicalTrials.gov ID
- NCT05319951
- Acronym / sponsor ID
- Different liquids intake
- Conditions
- Blood Donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,250 participants (actual)
- Lead sponsor
- Guangzhou Blood CenterOther government
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Rehydration Salts Power (iii) | Experimental | 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. |
| water with white granulated sugar | Experimental | Dietary Supplement: water with white granulated sugarDissolve 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. |
| recommended water intake | Placebo comparator | Dietary Supplement: waterRecommend the subjects to drink up 500ml water in 20 minutes prior to donation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Rehydration Salts power (iii)Also: Sichuan Emeishan Pharmaceutical Co., Ltd. 20210402 5100621103491Dissolve 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) |
| water with white granulated sugarDissolve 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 |
| waterRecommend the subjects to drink up 500ml water in 20 minutes prior to donation. | Dietary supplement | recommended water intake |
Primary outcome
vasovagal reaction rate
Time frame: 1-3days
vasovagal reaction rate in three groups
1 secondary outcome
rate of willingness to donate blood again
Time frame: 3days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guiyun Xie, MPH study chair
Guangzhou Blood Center
Jinyan Chen, MPH principal investigator
Guangzhou Blood Center
Shijie Li study director
Guangzhou Blood Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Rehydration Salts power (iii), water with white granulated sugar and water in people with Blood Donation, run by Guangzhou Blood Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vasovagal reaction rate (time frame: 1-3days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.