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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Cambridge
Sponsor:
Collaborators:
National Health Service, Blood and Transplant
University of Oxford
Information provided by (Responsible Party):
Professor Danesh, University of Cambridge
ClinicalTrials.gov Identifier:
NCT01610635
First received: May 31, 2012
Last updated: November 26, 2012
Last verified: November 2012
  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: 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

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • Total blood collected after two years [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Expressed in units (470ml) per person per year


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

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

  • Markers of iron status [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Serum ferritin and reticulocyte haemoglobin

  • Cognitive ability [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Reasoning, attention and memory

  • Levels of physical activity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Cost effectiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Donor attitudes, beliefs and values [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50000
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610635

Contacts
Contact: Carmel Moore, PhD +44 (0)1223 740893 csm47@medschl.cam.ac.uk

Locations
United Kingdom
Brentwood Blood Donor Centre Recruiting
Brentwood, Essex, United Kingdom, CM15 8DP
Edgware Blood Donor Centre Recruiting
Edgware, Middlesex, United Kingdom, HA8 0AD
Birmingham Blood Donor Centre Recruiting
Birmingham, United Kingdom, B2 4DU
Bradford Blood Donor Centre Recruiting
Bradford, United Kingdom, BD1 3SH
Bristol Blood Donor Centre Recruiting
Bristol, United Kingdom, BS10 5ND
Cambridge Blood Donor Centre Recruiting
Cambridge, United Kingdom, CB2 0PT
Gloucester Blood Donor Centre Recruiting
Gloucester, United Kingdom, GL1 3HF
Lancaster Blood Donor Centre Recruiting
Lancaster, United Kingdom, LA1 4GT
Leeds City Centre Blood Donor Centre Recruiting
Leeds, United Kingdom, LS1 5JX
Leeds Blood Donor Centre Recruiting
Leeds, United Kingdom, LS15 7TW
Leicester Blood Donor Centre Recruiting
Leicester, United Kingdom, LE1 4SJ
Liverpool Blood Donor Centre Recruiting
Liverpool, United Kingdom, L2 2BS
West End Blood Donor Centre Recruiting
London, United Kingdom, W1W 8NB
Tooting Blood Donor Centre Recruiting
London, United Kingdom, SW17 0RB
Luton Blood Donor Centre Recruiting
Luton, United Kingdom, LU1 2NF
Manchester Norfolk House Blood Donor Centre Recruiting
Manchester, United Kingdom, M2 1DW
Manchester Plymouth Grove Recruiting
Manchester, United Kingdom, M13 9LL
Newcastle Blood Donor Centre Recruiting
Newcastle, United Kingdom, NE2 4NQ
Nottingham Blood Donor Centre Recruiting
Nottingham, United Kingdom, NG7 1FR
Oxford Blood Donor Centre Recruiting
Oxford, United Kingdom, OX3 9DU
Plymouth Blood Donor Centre Recruiting
Plymouth, United Kingdom, PL6 8DH
Poole Blood Donor Centre Recruiting
Poole, United Kingdom, BH15 1SX
Sheffield Blood Donor Centre Recruiting
Sheffield, United Kingdom, S1 2GN
Southampton Blood Donor Centre Recruiting
Southampton, United Kingdom, SO16 5AF
Stoke Blood Donor Centre Recruiting
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:
No publications provided

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
Study First Received: May 31, 2012
Last Updated: November 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 29, 2014