Blood DonationINTERVALNCT01610635
INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
A study testing Reduced versus standard intervals between blood donations in people with Blood Donation, run by University of Cambridge at 25 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Donation
- What is being tested?
- Reduced versus standard intervals between blood donations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 25 sitesUnited Kingdom
- Study dates
- Jun 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United Kingdom25 sites
Birmingham Blood Donor Centre
Birmingham, B2 4DU
Bradford Blood Donor Centre
Bradford, BD1 3SH
Brentwood Blood Donor Centre
Brentwood, Essex, CM15 8DP
Bristol Blood Donor Centre
Bristol, BS10 5ND
Cambridge Blood Donor Centre
Cambridge, CB2 0PT
Edgware Blood Donor Centre
Edgware, Middlesex, HA8 0AD
Gloucester Blood Donor Centre
Gloucester, GL1 3HF
Lancaster Blood Donor Centre
Lancaster, LA1 4GT
Leeds City Centre Blood Donor Centre
Leeds, LS1 5JX
Leeds Blood Donor Centre
Leeds, LS15 7TW
Leicester Blood Donor Centre
Leicester, LE1 4SJ
Liverpool Blood Donor Centre
Liverpool, L2 2BS
Tooting Blood Donor Centre
London, SW17 0RB
West End Blood Donor Centre
London, W1W 8NB
Luton Blood Donor Centre
Luton, LU1 2NF
Manchester Plymouth Grove
Manchester, M13 9LL
Manchester Norfolk House Blood Donor Centre
Manchester, M2 1DW
Newcastle Blood Donor Centre
Newcastle, NE2 4NQ
Nottingham Blood Donor Centre
Nottingham, NG7 1FR
Oxford Blood Donor Centre
Oxford, OX3 9DU
Plymouth Blood Donor Centre
Plymouth, PL6 8DH
Poole Blood Donor Centre
Poole, BH15 1SX
Sheffield Blood Donor Centre
Sheffield, S1 2GN
Southampton Blood Donor Centre
Southampton, SO16 5AF
Stoke Blood Donor Centre
Stoke, ST1 4BT
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Donation
- Being tested
- Reduced versus standard intervals between blood donations
- Keywords
- RCT, blood donation frequency, quality of life, iron deficiency
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced versus standard intervals between blood donationsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Male - 8 weeks | Experimental | Male donors assigned to an 8 week donation interval frequency Receives: Other: Reduced versus standard intervals between blood donations |
| Male - 10 weeks | Experimental | Male donors assigned to 10 week donation interval frequency Receives: 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 Receives: Other: Reduced versus standard intervals between blood donations |
| Female - 14 weeks | Experimental | Female donors assigned to 14 week donation interval frequency Receives: Other: Reduced versus standard intervals between blood donations |
| Female - 16 weeks | No intervention | Female donors assigned to 16 week donation interval frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood collected after two years
Expressed in units (470ml) per person per year
Measured: 24 months
Secondary outcomes (7)
Donor quality of life
Measured using the SF-36 health survey
Measured: 24 months
Number of donation deferrals
Temporary rejection of donors due to low haemoglobin and other factors
Measured: 24 months
Markers of iron status
Serum ferritin and reticulocyte haemoglobin
Measured: 24 months
Cognitive ability
Reasoning, attention and memory
Measured: 24 months
Levels of physical activity
Measured: 24 months
Cost effectiveness
Measured: 24 months
Donor attitudes, beliefs and values
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, Blood and Transplant, University of Oxford
- Responsible party
- Principal investigator, Professor Danesh, University of Cambridge
- Investigators
- John Danesh, Principal investigator, University of CambridgeDavid Roberts, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610635
- Sponsor's protocol ID
- 11-01-GEN
- Other IDs
- 24760606
- Acronym
- INTERVAL
- Status last verified
- Jun 2015
- First submitted
- 31 May 2012
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial to Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased
- ClinicalTrials.gov ID
- NCT01610635
- Acronym / sponsor ID
- INTERVAL / 11-01-GEN
- Conditions
- Blood Donation
- Keywords
- RCT, blood donation frequency, quality of life, iron deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- National Health Service, Blood and Transplant, University of Oxford
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Male - 8 weeks | Experimental | Other: Reduced versus standard intervals between blood donationsMale donors assigned to an 8 week donation interval frequency |
| Male - 10 weeks | Experimental | Other: Reduced versus standard intervals between blood donationsMale donors assigned to 10 week donation interval frequency |
| Male - 12 weeks | No intervention | –Male donors assigned to 12 week donation interval frequency |
| Female - 12 weeks | Experimental | Other: Reduced versus standard intervals between blood donationsFemale donors assigned to 12 week donation interval frequency |
| Female - 14 weeks | Experimental | Other: Reduced versus standard intervals between blood donationsFemale donors assigned to 14 week donation interval frequency |
| Female - 16 weeks | No intervention | –Female donors assigned to 16 week donation interval frequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced versus standard intervals between blood donationsOver 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. | Other | Female - 12 weeks, Female - 14 weeks, Male - 10 weeks, Male - 8 weeks |
Primary outcome
Total blood collected after two years
Time frame: 24 months
Expressed in units (470ml) per person per year
7 secondary outcomes
Donor quality of life
Time frame: 24 months
Number of donation deferrals
Time frame: 24 months
Markers of iron status
Time frame: 24 months
Cognitive ability
Time frame: 24 months
Levels of physical activity
Time frame: 24 months
Cost effectiveness
Time frame: 24 months
Donor attitudes, beliefs and values
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- INTERVAL study webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Danesh principal investigator
University of Cambridge
David Roberts principal investigator
University of Oxford
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced versus standard intervals between blood donations in people with Blood Donation, run by University of Cambridge at 25 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total blood collected after two years (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.