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Be Part of Research - Trial Details - Understanding how critical illness and liver disease affect blood clotting

Understanding how critical illness and liver disease affect blood clotting

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Liver disease, critical illness, platelet function


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The blood that circulates within our bodies consists of many different cells, each with unique functions. One type of blood cell is the platelet; these cells become activated and attach to sites of injury to help form a blood clot and reduce or prevent further bleeding. In some unwell individuals, the number and/or function of these platelets can become altered. In many critically ill patients, the number of platelets can be reduced below a safe level, a condition known as thrombocytopenia. Thrombocytopenia is problematic, as in many cases, it is linked to worse patient outcomes. Within critically unwell patients, one group at risk of both thrombocytopenia and other bleeding disorders (e.g. overactivation of clotting) are patients with liver disease. Patients with liver disease in the Intensive Care Unit (ICU) at the Royal Berkshire Hospital (RBH) include those with established diseases such as alcohol-related cirrhosis, as well as those with liver dysfunction as part of their critical illness, for example, patients with sepsis. In this study, RBH and the University of Reading will collaborate to analyse the platelets using a range of complex, state-of-the-art techniques to study blood samples taken from patients with liver disease and critically unwell patients in the ICU at RBH. The goal is to analyse their platelet function in the laboratory and monitor how the function changes throughout their time in the ICU. This information will allow us to relate patient experiences, such as bleeding, clotting, and organ dysfunction, back to the laboratory results. While participation in this study will not have immediate benefits for the patients, upon the completion of this study, its results will be used to support future studies in making improvements to treatment strategies for this patient category.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 May 2024 01 Apr 2026

Observational

Intervention Type : Other
Intervention Description : This is an observational study, there are no interventions. The following is a brief summary of our methodologies.

A total of 30 patients will be recruited for this study from the ICU at the Royal Berkshire Hospital.

Up to 5, 50 ml blood samples will be taken from venous and/or arterial access during their stay in the ICU. An additional sample (not exceeding 50 ml) may also be requested when the patient is recovering on a ward.

Molecular analysis will also be performed on the samples of recalled patients to identify molecular differences in platelet function between the groups.

Several tests will be performed to understand which stage/ stages during platelet activation are affected in patients with liver disease as part of their critical illness. The tests performed will be carried out in an order which will make the best use of the blood samples taken from each individual participant.



Patients with pre-existing liver disease or acute liver dysfunction as part of their critical illness in the ICU
While the patient is in the ICU they will have blood taken from their indwelling vascular access devices which will allow for sampling of blood without any additional procedures being performed. At each sample, a maximum of 50 ml of blood will be taken each time up to a maximum of five separate occasions. Patients who are subsequently discharged onto a ward will then have a maximum of one other 50 ml sample taken as part of this study.

You can take part if:



You may not be able to take part if:


1. Patients on P2Y12 inhibitors (including clopidogrel, ticagrelor and prasugrel) 2. Patients on treatment-dose anticoagulation, including warfarin or novel anticoagulant drugs 3. Patients under 18 years of age 4. Active or recent malignancy (< 1 year) or on active treatment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Berkshire Hospital
    Royal Berkshire Hospital London Road
    Reading
    RG1 5AN
  • University of Reading
    School of Biological Sciences
    Reading
    RG6 6UR

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.


The study is sponsored by Royal Berkshire NHS Foundation Trust and funded by University of Reading Healthcare Innovation Partnership.




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Read full details for Trial ID: ISRCTN11565046
Last updated 25 April 2025

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