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

June 9, 2015 updated by: Professor Danesh, University of Cambridge

A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total blood collected after two years
Time Frame: 24 months
Expressed in units (470ml) per person per year
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost effectiveness
Time Frame: 24 months
24 months
Donor quality of life
Time Frame: 24 months
Measured using the SF-36 health survey
24 months
Number of donation deferrals
Time Frame: 24 months
Temporary rejection of donors due to low haemoglobin and other factors
24 months
Markers of iron status
Time Frame: 24 months
Serum ferritin and reticulocyte haemoglobin
24 months
Cognitive ability
Time Frame: 24 months
Reasoning, attention and memory
24 months
Levels of physical activity
Time Frame: 24 months
24 months
Donor attitudes, beliefs and values
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cambridge

Collaborators

University of Oxford
National Health Service, Blood and Transplant

Investigators

  • Principal Investigator: John Danesh, University of Cambridge
  • Principal Investigator: David Roberts, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

June 1, 2012

First Posted (ESTIMATE)

June 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-01-GEN
  • 24760606 (OTHER: ISRCTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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