Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-02-21 @ 6:47 PM
Study NCT ID:
NCT05319951
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2020-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-30', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vasovagal reaction rate', 'timeFrame': '1-3days', 'description': 'vasovagal reaction rate in three groups'}], 'secondaryOutcomes': [{'measure': 'rate of willingness to donate blood again', 'timeFrame': '3days', 'description': 'rate of willingness to donate blood again in three groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Donation']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nHowever, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:All blood donors donated whole blood in Guangzhou Blood Center during study.\n\n\\-\n\nExclusion Criteria:Blood donors who were deferral by blood screening result and other situations.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05319951', 'briefTitle': 'Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Guangzhou Blood Center'}, 'officialTitle': 'Effect of Different Liquids Intake in Vasovagal Reaction After Whole Blood Donation', 'orgStudyIdInfo': {'id': 'Different liquids intake'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Rehydration Salts Power (iii)', '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.', 'interventionNames': ['Drug: Oral Rehydration Salts power (iii)']}, {'type': 'EXPERIMENTAL', 'label': 'water with white granulated sugar', '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.', 'interventionNames': ['Dietary Supplement: water with white granulated sugar']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'recommended water intake', 'description': 'Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.', 'interventionNames': ['Dietary Supplement: water']}], 'interventions': [{'name': 'Oral Rehydration Salts power (iii)', 'type': 'DRUG', 'otherNames': ['Sichuan Emeishan Pharmaceutical Co., Ltd. 20210402 5100621103491'], '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.', 'armGroupLabels': ['Oral Rehydration Salts Power (iii)']}, {'name': 'water with white granulated sugar', 'type': 'DIETARY_SUPPLEMENT', '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.', 'armGroupLabels': ['water with white granulated sugar']}, {'name': 'water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Recommend the subjects to drink up 500ml water in 20 minutes prior to donation.', 'armGroupLabels': ['recommended water intake']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510095', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Blood Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Guiyun Xie, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangzhou Blood Center'}, {'name': 'Jinyan Chen, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangzhou Blood Center'}, {'name': 'Shijie Li', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangzhou Blood Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Blood Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}