Trauma Clinical Trial - RE-BLEED: A Digital Platform for Identifying

Status Active, not recruiting

Clinical Trial Summary

The RE-BLEED feasibility study aims to develop and test a real-time digital platform, whereby bleeding patients in-hospital can be identified and approached for their consent to participate in future research studies.

Clinical Trial Description

Bleeding affects up to 40% of all trauma patients, up to 30% of all surgery patients and is one of the commonest causes of death for women giving birth. The presentation and features of bleeding are different between patients - in some cases bleeding is very obvious to recognise, but in other cases bleeding is more "hidden", for example in the stomach. Bleeding must be stopped promptly to prevent severe illness or death. Many studies have shown differences in how patients who bleed are treated. There is also variation in how individual patients respond to the same treatment, with some patients doing better than others. Understanding how variation in practice and patient characteristics affect outcomes will help researchers and clinicians design and test improvements in care. Patients in hospital have regular tests that measure levels of the different types of cells in their blood and its ability to clot. For example, a drop in red blood cells can indicate that patients have suffered bleeding. More advanced blood tests are available that can provide more detailed information on why patients are bleeding and what treatments might be most effective. This study aims to develop a real-time, hospital-wide digital system to identify patients in hospital who have suffered from bleeding and test whether this system could be used in the future to potentially identify patients to recruit into trials of new treatments or blood tests. To do this, the investigators will: - Assemble a panel of experts to identify criteria (for example, specific blood test results and drug prescriptions) that could indicate a patient has suffered from bleeding - Use historical electronic patient records to test how well these criteria identify patients who have received treatments for bleeding (blood transfusion) - Develop and refine a web-based digital system where the most useful criteria can be applied in "real-time" to identify bleeding patients - Test how well the digital platform identifies bleeding patients - Test whether a significant number of patients identified by the digital platform are willing to allow their routine blood samples tested for blood clotting and endothelial factors. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05608577
Study type	Observational
Source	University of Oxford
Contact
Status	Active, not recruiting
Phase
Start date	October 1, 2021
Completion date	February 28, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

RE-BLEED: A Digital Platform for Identifying Bleeding Patients - a Feasibility Study — RE-BLEED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms