Threshold for Platelets Study (T4P)
Research type
Research Study
Full title
The Threshold for Platelets (T4P) study: a prospective randomised trial to define the platelet count below which critically ill patients should receive a platelet transfusion prior to an invasive procedure
IRAS ID
312405
Contact name
Peter Watkinson
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
ISRCTN Number
ISRCTN79371664
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
In the United Kingdom (UK), around 250,000 platelet transfusions are given out every year. Platelet transfusions are given when the number of platelets in the blood (the platelet count) falls below a certain level (the transfusion threshold). Platelet transfusions are commonly given in Intensive Care Units (ICU) as patients in ICU often have fewer platelets in their blood than healthy people. In ICUs, platelet transfusions are mainly given to try and prevent bleeding, for example during a procedure.
However, platelet transfusions also have risks, such as an allergic reaction, and may not work as well in ICU patients. We do not know to what level the platelet count should fall (the best transfusion threshold) before the benefits of giving platelet transfusions outweigh the risks. As a result, a wide range of transfusion thresholds are currently used in ICUs to decide when platelet transfusions should be given.
Therefore, we intend to carry out a large clinical trial to find out the best transfusion threshold below which platelet transfusions should be given to patients who need an invasive procedure in ICU. The study will include 2,550 patients from around 66 UK NHS ICUs. Patients will be randomly allocated (by chance) to one of five platelet transfusion thresholds. If their platelet count drops below their allocated threshold, they will be given a platelet transfusion before their procedure. We will follow up all patients, after 90 days and one year, by ‘linking’ study data with routinely collected national records. We will work out the best transfusion threshold by comparing the number of patients alive in each group at 90 days.
Patient recruitment will start in mid-2022 and end in 2026. The results will have a large and immediate impact on ICU clinical practice, as well as wider benefits throughout the NHS.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0186
Date of REC Opinion
8 Jul 2022
REC opinion
Favourable Opinion