RecruitingInterventional

Evaluating the efficiency and safety of varying frequency and volumes of plasma donation: A large-scale study to SHAPE NHSBT’s Plasma donation strategies (SHAPE-Plasma)

The SHAPE-Plasma study wants to find the best and safest ways for people to donate plasma. Plasma donations are really important for making medicines that help around 17,000 people in England every year. Since the ban on using UK plasma was lifted recently, it's vital to learn how to collect it efficiently and safely. This study will involve about 6,500 plasma donors to test different donation schedules, amounts, and ways to encourage people to keep donating. The main goal is to increase the UK's supply of plasma for life-saving treatments, while making sure donor health is always a top priority.

At a glance

Status

Recruiting

Sponsor

University of Cambridge

Enrolment target

6,875

Start

02 Jun 2025

Estimated completion

29 Sep 2027

Plasma donor health

What is this study about?

The NHS Blood and Transplant (NHSBT) aims to increase the amount of plasma collected in the UK. This is really important because plasma is used to make medicines that save and improve the lives of many people every year. For a long time, there was a ban on using plasma from UK donors, but that has now been lifted. This means we need to find the best and safest ways to collect plasma again, as it's been 25 years since serious research was done on this in the UK.

This study, called SHAPE-Plasma, is a big effort to figure out exactly how often and how much plasma someone can donate without it affecting their health. We also want to understand what encourages people to continue donating in the long run. By finding these answers, the NHS can make sure they collect enough plasma to meet the growing need for these vital medicines, helping more patients across England.

Around 6,500 plasma donors will take part in this research at NHSBT centres in England. Your participation would help shape the future of plasma donation, making it safer and more efficient for everyone. Even though there are no direct benefits to you as a participant, your involvement will greatly help future plasma donors and patients who rely on these life-saving treatments. The study is carefully designed to minimise any risks to donors.

Key takeaways

The study aims to improve plasma donation safety and efficiency in the UK.
It tests different donation frequencies, volumes, and booking methods.
Around 6,500 plasma donors will participate in the study.
Your involvement will last for one year, including donations, blood samples, and questionnaires.
Data collected will help benefit future plasma donors and patients needing plasma medicines.
You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old. You must also meet all the usual health requirements that NHSBT has for plasma donors. This means you should be generally well and able to donate plasma safely.

You also need to be open to how the study works. This involves being happy to be placed into any of the study groups, which might mean donating at different times or amounts than you currently do. You would also need to be able to donate at one of the study's specific donation centres for the whole time you are involved in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you already meet the standard health requirements for donating plasma?
Are you willing to follow a specific donation schedule and volume set by the study?
Can you donate at an NHSBT centre in Birmingham, Reading, or Twickenham for the study period?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first read and sign a consent form, which will be done electronically. You'll be asked to provide your height and weight so the team can work out how much plasma you can safely donate.

After signing the form, you'll be randomly put into different groups. This means: (1) you'll be assigned a donation schedule, either every 2, 4, or 8 weeks; (2) you'll donate either the current amount of plasma or a slightly different, personalised amount (between 560ml and 800ml); and (3) you'll either book your next appointment as usual or be asked to book it using the NHSBT app while you're at the centre.

You'll also give a small blood sample (about 2 teaspoons) for research purposes during your first study donation and again about a year later; these will be taken at the same time as your routine donation. Additionally, every 8 weeks, you'll receive an email with a short online questionnaire (around 10 minutes) about your recent donation experience and general wellbeing. The researchers will also look at your health information from your donation records. Your involvement will last for 1 year, though researchers may look at health records for longer to follow up.

Potential risks and benefits

There won't be any immediate, direct benefits to you by taking part in this study. However, the information gathered will be very valuable for improving plasma donation strategies in the UK, which will benefit future plasma donors and the many patients who rely on these vital medicines. The study is designed with your safety in mind, and the risk of harm is very small. The main purpose of this research is to make plasma donation even safer. However, please be assured that insurance is in place to provide support if any harm were to occur due to negligence during your participation. You are free to withdraw from the study at any time without giving a reason.

Locations (3)

Birmingham Donor Centre
City only
Birmingham, England
Twickenham Donor Centre
City only
Twickenham, England
Reading Donor Centre
Approximate
Reading, England

Common questions

Why is this study important?

It helps the NHS collect enough plasma for life-saving medicines and ensures donor safety, especially since the ban on UK plasma was recently lifted.

How long will I be involved in the study?

Your direct involvement in the study, including donations and questionnaires, will last for about one year.

Will I get to choose how often I donate or the amount?

No, you will be randomly assigned to different groups, which means your donation frequency and volume will be decided by the study design, not by you.

What happens if I change my mind about participating?

You can withdraw from the study at any time without needing to give a reason, and it won't affect any future donations or care you receive.

Where will the study take place?

The study is being run at NHSBT plasma donation centres in Birmingham, Reading, and Twickenham.

How to find out more

Elisha Johnson

ejt70@medschl.cam.ac.uk +44 800 021 7182 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.