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

Blood Donation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Blood Donation

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other: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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Male - 8 weeksMale donors assigned to an 8 week donation interval frequency

Male - 10 weeksMale donors assigned to 10 week donation interval frequency

Male - 12 weeksMale donors assigned to 12 week donation interval frequency

Female - 12 weeksFemale donors assigned to 12 week donation interval frequency

Female - 14 weeksFemale donors assigned to 14 week donation interval frequency

Female - 16 weeksFemale donors assigned to 16 week donation interval frequency

Study Status

Unknown status

Start Date: June 2012

Completed Date: December 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Total blood collected after two years

Secondary Outcome: Donor quality of life

Study sponsors, principal investigator, and references

Principal Investigator: John Danesh

Lead Sponsor: University of Cambridge

Collaborator: National Health Service, Blood and Transplant

More information:https://clinicaltrials.gov/show/NCT01610635

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