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

Sponsor
University of Cambridge (Other)
Overall Status
Unknown status
CT.gov ID
NCT01610635
Collaborator
National Health Service, Blood and Transplant (Other), University of Oxford (Other)
50,000
Enrollment
25
Locations
6
Arms
54
Duration (Months)
2000
Patients Per Site
37
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Reduced versus standard intervals between blood donations
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50000 participants
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
Study Start Date :
Jun 1, 2012
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Total blood collected after two years [24 months]

    Expressed in units (470ml) per person per year

Secondary Outcome Measures

  1. Donor quality of life [24 months]

    Measured using the SF-36 health survey

  2. Number of donation deferrals [24 months]

    Temporary rejection of donors due to low haemoglobin and other factors

  3. Markers of iron status [24 months]

    Serum ferritin and reticulocyte haemoglobin

  4. Cognitive ability [24 months]

    Reasoning, attention and memory

  5. Levels of physical activity [24 months]

  6. Cost effectiveness [24 months]

  7. Donor attitudes, beliefs and values [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Brentwood Blood Donor Centre Brentwood Essex United Kingdom CM15 8DP
2 Edgware Blood Donor Centre Edgware Middlesex United Kingdom HA8 0AD
3 Birmingham Blood Donor Centre Birmingham United Kingdom B2 4DU
4 Bradford Blood Donor Centre Bradford United Kingdom BD1 3SH
5 Bristol Blood Donor Centre Bristol United Kingdom BS10 5ND
6 Cambridge Blood Donor Centre Cambridge United Kingdom CB2 0PT
7 Gloucester Blood Donor Centre Gloucester United Kingdom GL1 3HF
8 Lancaster Blood Donor Centre Lancaster United Kingdom LA1 4GT
9 Leeds City Centre Blood Donor Centre Leeds United Kingdom LS1 5JX
10 Leeds Blood Donor Centre Leeds United Kingdom LS15 7TW
11 Leicester Blood Donor Centre Leicester United Kingdom LE1 4SJ
12 Liverpool Blood Donor Centre Liverpool United Kingdom L2 2BS
13 Tooting Blood Donor Centre London United Kingdom SW17 0RB
14 West End Blood Donor Centre London United Kingdom W1W 8NB
15 Luton Blood Donor Centre Luton United Kingdom LU1 2NF
16 Manchester Plymouth Grove Manchester United Kingdom M13 9LL
17 Manchester Norfolk House Blood Donor Centre Manchester United Kingdom M2 1DW
18 Newcastle Blood Donor Centre Newcastle United Kingdom NE2 4NQ
19 Nottingham Blood Donor Centre Nottingham United Kingdom NG7 1FR
20 Oxford Blood Donor Centre Oxford United Kingdom OX3 9DU
21 Plymouth Blood Donor Centre Plymouth United Kingdom PL6 8DH
22 Poole Blood Donor Centre Poole United Kingdom BH15 1SX
23 Sheffield Blood Donor Centre Sheffield United Kingdom S1 2GN
24 Southampton Blood Donor Centre Southampton United Kingdom SO16 5AF
25 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None 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
Other Study ID Numbers:
  • 11-01-GEN
  • 24760606
First Posted:
Jun 4, 2012
Last Update Posted:
Jun 10, 2015
Last Verified:
Jun 1, 2015
Keywords provided by Professor Danesh, Professor of Epidemiology and Medicine, Head of Department of Public Health and Primary Care, University of Cambridge
RCT
blood donation frequency
quality of life
iron deficiency

Study Results

No Results Posted as of Jun 10, 2015