For patients

We are the Intensive Care National Audit and Research Centre (ICNARC), an independent registered charity (charity number: 1039417) and UK Clinical Research Collaboration registered Clinical Trials Unit (ID number 42) based in the UK. The University of Oxford is the Sponsor and Data Controller for the T4P trial and are responsible for looking after your information and using it properly. The study is managed by ICNARC, who are a data processor for the University of Oxford.

This research study aims to better understand when platelet transfusions should be given to patients with a low platelet count before an invasive procedure.

Platelets are cells in your blood that help form clots and stop bleeding. People treated in a critical care unit often have a low number of platelets (platelet count) in their blood because they are very unwell. Whilst they are in critical care, they might need a medical procedure as part of their treatment. Platelet transfusions are sometimes given before these procedures if the patient’s platelet count is low. This is thought to reduce the possible risk of bleeding from the procedure. However, platelet transfusions also carry risks such as inflammation, infection, and allergic reactions, and may not work as effectively in unwell patients.

Currently, we do not know the platelet count below which giving a platelet transfusion might be beneficial when the procedure itself poses a low bleeding risk. Surveys of doctors working in UK critical care units have shown uncertainty over the platelet count below which doctors should give a platelet transfusion. As a result, platelet transfusions are currently given to patients with a wide range of different platelet counts and there is no set threshold.

The lack of high-quality evidence looking at the platelet count below which a platelet transfusion should be given, where the benefits outweigh the risks, makes this study important. This study will test five different thresholds to find out the safest count below which platelet transfusions should be given before invasive procedures, posing a low bleeding risk, are carried out in intensive care. This research will improve the future treatment of patients in the NHS and around the world.

The T4P Trial will recruit 2,550 patients from approximately 66 NHS hospitals across the UK.

This work is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (project number: NIHR131822). This research is also covered by an Emergency Waiver of Consent under the Mental Capacity Act (approved by South Central – Oxford C Research Ethics Committee (reference: 22/SC/0186)).  This means eligible patients will be randomised to receive the assigned treatment as soon as possible, and consented later after the emergency has passed.

In order to allow us to meet the objectives of this trial, we will obtain and process personal data for trial participants. This information (such as date of birth, NHS number, health data and contact details) are collected by the research team at the hospital where participants were included in the trial. For the duration of the trial, the research team will also collect information from participant’s medical records about their well-being. Other important health information will be collected from national NHS databases. Participants will also be sent short health questionnaires at 90 days and one year after recruitment into the study.

We will use information that is already routinely recorded in a participant’s medical records for this study and will use the minimum personally-identifiable information possible. This will include information already usually held by the NHS, including by the Local NHS Trust, NHS Digital and Digital Health and Care Wales, and national clinical audits.

The personally-identifiable information from the Local NHS Trust is provided via a secure, restricted access database, accessible to authorised research team members at the local hospital and the ICNARC research team. Appropriate members of the ICNARC research team will then provide a list of participant’s core data (date of birth, home postcode, NHS number and unique trial number, required to ensure a participant can be correctly identified in the national databases) to NHS Digital or Digital Health and Care Wales, who in return, will provide survival and hospital stay information.

As part of the project, ICNARC will securely share de-personalised data with a Health Economist at the London School of Hygiene and Tropical Medicine (LSHTM) for the purpose of data analysis and to test whether interventions are cost-effective for the NHS. Researchers at LSHTM will not be able to identify individuals within the data they receive.

To collect and process personal data in this trial, as Sponsor and Data Controller, the University of Oxford relies upon Article 6(1)(e), of the UK General Data Protection Regulation (UK GDPR), which is “a task in the public interest”. The aim of processing data is to conduct the statistical analysis necessary for meeting the objectives of the trial, therefore special category data are processed for the interest of scientific, statistical and research purposes (Article 9(2)(j) of UK GDPR).

Data are stored on ICNARC’s secure servers which are managed and hosted by Exponential-e. ICNARC ensures this information is protected and makes regular back-ups of the data and servers are regularly monitored for possible vulnerabilities and attacks.  ICNARC also contracts Babble Cloud, an IT support company to provide IT support to ICNARC staff and the equipment they use. ICNARC has contracts with Exponential-e and Babble Cloud, including a data processing agreement which says what their staff can and cannot do with your data and although they do have access to ICNARC servers they are not permitted to access your data without prior authorisation.

ICNARC holds all data with the strictest confidence. All staff adhere to our internal policies and procedures and are regularly trained in data protection.

ICNARC will keep personal identifiable information for up to one year after the study, including analysis, ends. This is to allow for review and verification of our results and analysis. The research information will then be totally anonymised so that a participant can no longer be identified, and that data will be held for a minimum of 10 years. The anonymous data may be shared with authorised researchers within and outside of ICNARC, for further analyses or to inform future studies.

Where we publish papers or present our research findings at conferences and other events, it will not be possible to identify any individual who has taken part in the study.

If a participant agreed for us to keep their contact details on file after the study ends, to be notified of other research and feedback opportunities, we will separately retain these details for 10 years and may contact participant’s if we feel they or their data could contribute to other related and important health research.

Subject to certain conditions, you have the following rights in relation to your personal data:

• Right of access – you have the right to request a copy of the information that we hold about you
• Right of rectification – you have a right to correct data that we hold about you that is inaccurate or incomplete
• Right to erasure – in certain circumstances you can ask for the data we hold about you to be erased from our records
• Right to restriction of processing – where certain conditions apply to have a right to restrict the processing
• Right of portability – you have the right to have the data we hold about you transferred to another organisation
• Right to object – you have the right to object to certain types of processing such as direct marketing
• Right to object to automated processing, including profiling – you also have the right to be subject to the legal effects of automated processing or profiling

Intensive Care National Audit & Research Centre (ICNARC)
Napier House
24 High Holborn
London
WC1V 6AZ
Tel: 020 7831 6878
Email: icnarc@icnarc.org

The Data Protection Officer at ICNARC is Scott Carnegie. Further information is available by emailing DPO@icnarc.org  or by contacting the office on 0207 7831 6878.

In the event you wish to make a complaint about how your personal data is being processed by ICNARC, or how your complaint has been handled, you have the right to lodge a complaint with ICNARC’s Data Protection Officer (above) or directly with the supervisory authority:

Supervisory authority contact details

ICO – Information Commissioner’s Office

Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
https://ico.org.uk/global/contact-us/
Tel: 0303 123 1113