SHAPE-Plasma, V1.0
Research type
Research Study
Full title
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).
IRAS ID
348298
Contact name
Carolyn Read
Contact email
Sponsor organisation
University of Cambridge
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Plasma-derived medicines have significantly improved the lives of millions over the past 50 years. While global demand for whole blood has decreased, demand for plasma products has grown. The UK has relied on imported plasma for over 25 years, but the 2021 removal of the ban on UK plasma provides an opportunity for NHS Blood and Transplant (NHSBT) to explore the best methods for plasma collection.
Plasma collection practices vary globally, from donations every two days to every two weeks. Increasing the frequency and volume of plasma collection could boost supply, but the impact on donor safety is unclear, and more research is needed to guide medical guidelines.
To address this, we plan to conduct a trial to determine the optimal donation frequency and volume. Donors will give plasma every 2, 4, or 8 weeks, with different volumes taken. Donors will be randomly assigned to either book their appointments as usual or be prompted to schedule the next one via the NHSBT app during their current donation.
We will look at the donors' blood markers and ask them about their health and lifestyle to factor in how this influences their health after plasma donation. This will be a randomised trial which means that the plasma donors will be randomly given one the frequencies, volumes, and appointment booking. That means we can confidently compare the new regimes with current ones to see which is better.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0259
Date of REC Opinion
8 Jan 2025
REC opinion
Further Information Favourable Opinion