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

NCT01610635 | Unknown DMC

• 2 other identifiers: 11-01-GEN24760606
• Study Type: interventional
• Target: 50,000
• Locations: 1 country
• Sites: 25

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.

Conditions

Blood Donation

Keywords

RCT; blood donation frequency; quality of life; iron deficiency

Outcome Measures

Primary Outcomes (1)

• Total blood collected after two years

  Expressed in units (470ml) per person per year

  24 months

Secondary Outcomes (7)

• Donor quality of life

  24 months

• Number of donation deferrals

  24 months

• Markers of iron status

  24 months

• Cognitive ability

  24 months

• Levels of physical activity

  24 months

Study Arms (6)

Male - 8 weeks

EXPERIMENTAL

Male donors assigned to an 8 week donation interval frequency

Other: Reduced versus standard intervals between blood donations

Male - 10 weeks

EXPERIMENTAL

Male donors assigned to 10 week donation interval frequency

Other: Reduced versus standard intervals between blood donations

Male - 12 weeks

NO INTERVENTION

Male donors assigned to 12 week donation interval frequency

Female - 12 weeks

EXPERIMENTAL

Female donors assigned to 12 week donation interval frequency

Other: Reduced versus standard intervals between blood donations

Female - 14 weeks

EXPERIMENTAL

Female donors assigned to 14 week donation interval frequency

Other: Reduced versus standard intervals between blood donations

Female - 16 weeks

NO INTERVENTION

Female donors assigned to 16 week donation interval frequency

Interventions

Reduced versus standard intervals between blood donations OTHER

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.

Female - 12 weeks; Female - 14 weeks; Male - 10 weeks; Male - 8 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cambridge: lead
• National Health Service, Blood and Transplant: collaborator
• University of Oxford: collaborator

Study Sites (25)

Brentwood Blood Donor Centre

Brentwood, Essex, CM15 8DP, United Kingdom

Location

Edgware Blood Donor Centre

Edgware, Middlesex, HA8 0AD, United Kingdom

Location

Birmingham Blood Donor Centre

Birmingham, B2 4DU, United Kingdom

Location

Bradford Blood Donor Centre

Bradford, BD1 3SH, United Kingdom

Location

Bristol Blood Donor Centre

Bristol, BS10 5ND, United Kingdom

Location

Cambridge Blood Donor Centre

Cambridge, CB2 0PT, United Kingdom

Location

Gloucester Blood Donor Centre

Gloucester, GL1 3HF, United Kingdom

Location

Lancaster Blood Donor Centre

Lancaster, LA1 4GT, United Kingdom

Location

Leeds City Centre Blood Donor Centre

Leeds, LS1 5JX, United Kingdom

Location

Leeds Blood Donor Centre

Leeds, LS15 7TW, United Kingdom

Location

Leicester Blood Donor Centre

Leicester, LE1 4SJ, United Kingdom

Location

Liverpool Blood Donor Centre

Liverpool, L2 2BS, United Kingdom

Location

Tooting Blood Donor Centre

London, SW17 0RB, United Kingdom

Location

West End Blood Donor Centre

London, W1W 8NB, United Kingdom

Location

Luton Blood Donor Centre

Luton, LU1 2NF, United Kingdom

Location

Manchester Plymouth Grove

Manchester, M13 9LL, United Kingdom

Location

Manchester Norfolk House Blood Donor Centre

Manchester, M2 1DW, United Kingdom

Location

Newcastle Blood Donor Centre

Newcastle, NE2 4NQ, United Kingdom

Location

Nottingham Blood Donor Centre

Nottingham, NG7 1FR, United Kingdom

Location

Oxford Blood Donor Centre

Oxford, OX3 9DU, United Kingdom

Location

Plymouth Blood Donor Centre

Plymouth, PL6 8DH, United Kingdom

Location

Poole Blood Donor Centre

Poole, BH15 1SX, United Kingdom

Location

Sheffield Blood Donor Centre

Sheffield, S1 2GN, United Kingdom

Location

Southampton Blood Donor Centre

Southampton, SO16 5AF, United Kingdom

Location

Stoke Blood Donor Centre

Stoke, ST1 4BT, United Kingdom

Location

Related Links

• ISRCTN study record
• INTERVAL study webpage

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• John Danesh

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• David Roberts

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology and Medicine, Head of Department of Public Health and Primary Care

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

GB (25)