Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-30 @ 2:49 PM
Study NCT ID:
NCT01610635
Status:
UNKNOWN
Last Update Posted:
2015-06-10
First Post:
2012-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-09', 'studyFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2012-06-01', 'lastUpdatePostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total blood collected after two years', 'timeFrame': '24 months', 'description': 'Expressed in units (470ml) per person per year'}], 'secondaryOutcomes': [{'measure': 'Donor quality of life', 'timeFrame': '24 months', 'description': 'Measured using the SF-36 health survey'}, {'measure': 'Number of donation deferrals', 'timeFrame': '24 months', 'description': 'Temporary rejection of donors due to low haemoglobin and other factors'}, {'measure': 'Markers of iron status', 'timeFrame': '24 months', 'description': 'Serum ferritin and reticulocyte haemoglobin'}, {'measure': 'Cognitive ability', 'timeFrame': '24 months', 'description': 'Reasoning, attention and memory'}, {'measure': 'Levels of physical activity', 'timeFrame': '24 months'}, {'measure': 'Cost effectiveness', 'timeFrame': '24 months'}, {'measure': 'Donor attitudes, beliefs and values', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RCT', 'blood donation frequency', 'quality of life', 'iron deficiency'], 'conditions': ['Blood Donation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.controlled-trials.com/ISRCTN24760606/ISRCTN24760606', 'label': 'ISRCTN study record'}, {'url': 'http://www.intervalstudy.org.uk', 'label': 'INTERVAL study webpage'}]}, 'descriptionModule': {'briefSummary': 'It is hypothesised that the number of donations made by English blood donors will be greater with reduced vs. standard inter-donation intervals. The null hypothesis is that there will be no difference in donations between treatment groups; this may arise if reduced inter-donation intervals result in a greater number of donation deferrals (due to low haemoglobin) and/or an unacceptable burden to donors.', 'detailedDescription': "50,000 blood donors will be recruited from permanent blood donation centres across England to compare different intervals between blood donations to try to find the optimum interval for which it is safe for different donors to give blood. The study will look at whether intervals should be tailored by age, gender, genetic profile, and other characteristics. Study findings should help to improve the well-being of future blood donors in England and enhance the country's blood supplies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 years or older and fulfilling all normal criteria for blood donation\n2. Willing to be assigned to any of the study intervention groups\n3. Registered at one of the permanent donation clinics at the time of enrolment\n\nExclusion Criteria:\n\n* As the aim of the study is to be almost "paper-less", it will involve remote web-based data collection. Hence, participants who do not have internet access and/or are not willing to provide an email address for study correspondence will be excluded.'}, 'identificationModule': {'nctId': 'NCT01610635', 'acronym': 'INTERVAL', 'briefTitle': 'INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased', 'organization': {'class': 'OTHER', 'fullName': 'University of Cambridge'}, 'officialTitle': 'A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased', 'orgStudyIdInfo': {'id': '11-01-GEN'}, 'secondaryIdInfos': [{'id': '24760606', 'type': 'OTHER', 'domain': 'ISRCTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Male - 8 weeks', 'description': 'Male donors assigned to an 8 week donation interval frequency', 'interventionNames': ['Other: Reduced versus standard intervals between blood donations']}, {'type': 'EXPERIMENTAL', 'label': 'Male - 10 weeks', 'description': 'Male donors assigned to 10 week donation interval frequency', 'interventionNames': ['Other: Reduced versus standard intervals between blood donations']}, {'type': 'NO_INTERVENTION', 'label': 'Male - 12 weeks', 'description': 'Male donors assigned to 12 week donation interval frequency'}, {'type': 'EXPERIMENTAL', 'label': 'Female - 12 weeks', 'description': 'Female donors assigned to 12 week donation interval frequency', 'interventionNames': ['Other: Reduced versus standard intervals between blood donations']}, {'type': 'EXPERIMENTAL', 'label': 'Female - 14 weeks', 'description': 'Female donors assigned to 14 week donation interval frequency', 'interventionNames': ['Other: Reduced versus standard intervals between blood donations']}, {'type': 'NO_INTERVENTION', 'label': 'Female - 16 weeks', 'description': 'Female donors assigned to 16 week donation interval frequency'}], 'interventions': [{'name': 'Reduced versus standard intervals between blood donations', 'type': 'OTHER', 'description': 'Over a period of two years participants will be invited to give blood either at usual donation intervals or more frequently. Men will be invited to donate every 12, 10 or 8 weeks and women every 16, 14 or 12 weeks.', 'armGroupLabels': ['Female - 12 weeks', 'Female - 14 weeks', 'Male - 10 weeks', 'Male - 8 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CM15 8DP', 'city': 'Brentwood', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Brentwood Blood Donor Centre', 'geoPoint': {'lat': 51.62127, 'lon': 0.30556}}, {'zip': 'HA8 0AD', 'city': 'Edgware', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Edgware Blood Donor Centre', 'geoPoint': {'lat': 51.6128, 'lon': -0.27539}}, {'zip': 'B2 4DU', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham Blood Donor Centre', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BD1 3SH', 'city': 'Bradford', 'country': 'United Kingdom', 'facility': 'Bradford Blood Donor Centre', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'BS10 5ND', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Blood Donor Centre', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 0PT', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge Blood Donor Centre', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'GL1 3HF', 'city': 'Gloucester', 'country': 'United Kingdom', 'facility': 'Gloucester Blood Donor Centre', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'zip': 'LA1 4GT', 'city': 'Lancaster', 'country': 'United Kingdom', 'facility': 'Lancaster Blood Donor Centre', 'geoPoint': {'lat': 54.04649, 'lon': -2.79988}}, {'zip': 'LS1 5JX', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds City Centre Blood Donor Centre', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LS15 7TW', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Blood Donor Centre', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE1 4SJ', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Blood Donor Centre', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'L2 2BS', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool Blood Donor Centre', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SW17 0RB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Tooting Blood Donor Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1W 8NB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'West End Blood Donor Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'LU1 2NF', 'city': 'Luton', 'country': 'United Kingdom', 'facility': 'Luton Blood Donor Centre', 'geoPoint': {'lat': 51.87967, 'lon': -0.41748}}, {'zip': 'M13 9LL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Plymouth Grove', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'M2 1DW', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Norfolk House Blood Donor Centre', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NE2 4NQ', 'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Newcastle Blood Donor Centre', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'NG7 1FR', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham Blood Donor Centre', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford Blood Donor Centre', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PL6 8DH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Plymouth Blood Donor Centre', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'BH15 1SX', 'city': 'Poole', 'country': 'United Kingdom', 'facility': 'Poole Blood Donor Centre', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'S1 2GN', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Sheffield Blood Donor Centre', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'SO16 5AF', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Southampton Blood Donor Centre', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'ST1 4BT', 'city': 'Stoke', 'country': 'United Kingdom', 'facility': 'Stoke Blood Donor Centre', 'geoPoint': {'lat': 53.25, 'lon': -2.86667}}], 'overallOfficials': [{'name': 'John Danesh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cambridge'}, {'name': 'David Roberts', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cambridge', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Service, Blood and Transplant', 'class': 'UNKNOWN'}, {'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Epidemiology and Medicine, Head of Department of Public Health and Primary Care', 'investigatorFullName': 'Professor Danesh', 'investigatorAffiliation': 'University of Cambridge'}}}}