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INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased (INTERVAL)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Professor Danesh, University of Cambridge.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01610635
First Posted: June 4, 2012
Last Update Posted: June 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Health Service, Blood and Transplant
University of Oxford
Information provided by (Responsible Party):
Professor Danesh, University of Cambridge
  Purpose
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.

Condition Intervention
Blood Donation Other: Reduced versus standard intervals between blood donations

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased

Further study details as provided by Professor Danesh, University of Cambridge:

Primary Outcome Measures:
  • Total blood collected after two years [ Time Frame: 24 months ]
    Expressed in units (470ml) per person per year


Secondary Outcome Measures:
  • Donor quality of life [ Time Frame: 24 months ]
    Measured using the SF-36 health survey

  • Number of donation deferrals [ Time Frame: 24 months ]
    Temporary rejection of donors due to low haemoglobin and other factors

  • Markers of iron status [ Time Frame: 24 months ]
    Serum ferritin and reticulocyte haemoglobin

  • Cognitive ability [ Time Frame: 24 months ]
    Reasoning, attention and memory

  • Levels of physical activity [ Time Frame: 24 months ]
  • Cost effectiveness [ Time Frame: 24 months ]
  • Donor attitudes, beliefs and values [ Time Frame: 24 months ]

Estimated Enrollment: 50000
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Male - 8 weeks
Male donors assigned to an 8 week donation interval frequency
Other: Reduced versus standard intervals between blood donations
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.
Experimental: Male - 10 weeks
Male donors assigned to 10 week donation interval frequency
Other: Reduced versus standard intervals between blood donations
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.
No Intervention: Male - 12 weeks
Male donors assigned to 12 week donation interval frequency
Experimental: Female - 12 weeks
Female donors assigned to 12 week donation interval frequency
Other: Reduced versus standard intervals between blood donations
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.
Experimental: Female - 14 weeks
Female donors assigned to 14 week donation interval frequency
Other: Reduced versus standard intervals between blood donations
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.
No Intervention: Female - 16 weeks
Female donors assigned to 16 week donation interval frequency

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 18 years or older and fulfilling all normal criteria for blood donation
  2. Willing to be assigned to any of the study intervention groups
  3. Registered at one of the permanent donation clinics at the time of enrolment

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610635


Locations
United Kingdom
Brentwood Blood Donor Centre
Brentwood, Essex, United Kingdom, CM15 8DP
Edgware Blood Donor Centre
Edgware, Middlesex, United Kingdom, HA8 0AD
Birmingham Blood Donor Centre
Birmingham, United Kingdom, B2 4DU
Bradford Blood Donor Centre
Bradford, United Kingdom, BD1 3SH
Bristol Blood Donor Centre
Bristol, United Kingdom, BS10 5ND
Cambridge Blood Donor Centre
Cambridge, United Kingdom, CB2 0PT
Gloucester Blood Donor Centre
Gloucester, United Kingdom, GL1 3HF
Lancaster Blood Donor Centre
Lancaster, United Kingdom, LA1 4GT
Leeds City Centre Blood Donor Centre
Leeds, United Kingdom, LS1 5JX
Leeds Blood Donor Centre
Leeds, United Kingdom, LS15 7TW
Leicester Blood Donor Centre
Leicester, United Kingdom, LE1 4SJ
Liverpool Blood Donor Centre
Liverpool, United Kingdom, L2 2BS
Tooting Blood Donor Centre
London, United Kingdom, SW17 0RB
West End Blood Donor Centre
London, United Kingdom, W1W 8NB
Luton Blood Donor Centre
Luton, United Kingdom, LU1 2NF
Manchester Plymouth Grove
Manchester, United Kingdom, M13 9LL
Manchester Norfolk House Blood Donor Centre
Manchester, United Kingdom, M2 1DW
Newcastle Blood Donor Centre
Newcastle, United Kingdom, NE2 4NQ
Nottingham Blood Donor Centre
Nottingham, United Kingdom, NG7 1FR
Oxford Blood Donor Centre
Oxford, United Kingdom, OX3 9DU
Plymouth Blood Donor Centre
Plymouth, United Kingdom, PL6 8DH
Poole Blood Donor Centre
Poole, United Kingdom, BH15 1SX
Sheffield Blood Donor Centre
Sheffield, United Kingdom, S1 2GN
Southampton Blood Donor Centre
Southampton, United Kingdom, SO16 5AF
Stoke Blood Donor Centre
Stoke, United Kingdom, ST1 4BT
Sponsors and Collaborators
University of Cambridge
National Health Service, Blood and Transplant
University of Oxford
Investigators
Principal Investigator: John Danesh University of Cambridge
Principal Investigator: David Roberts University of Oxford
  More Information

Additional Information:
Responsible Party: Professor Danesh, Professor of Epidemiology and Medicine, Head of Department of Public Health and Primary Care, University of Cambridge
ClinicalTrials.gov Identifier: NCT01610635     History of Changes
Other Study ID Numbers: 11-01-GEN
24760606 ( Other Identifier: ISRCTN )
First Submitted: May 31, 2012
First Posted: June 4, 2012
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Professor Danesh, University of Cambridge:
RCT
blood donation frequency
quality of life
iron deficiency