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

Trauma Clinical Trial

— RE-BLEED  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05608577
• Other study ID #: PID15451
• Status: Active, not recruiting
• Start date: October 1, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: August 2023
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 110 Years

Eligibility

Inclusion Criteria:

Retrospective cohort:

• Adults aged between 16 and 110

• Admitted to hospital (Oxford University Hospitals NHS Foundation Trust) or attended the emergency department between 1/3/2011 to 31/8/2023

Prospective cohort:

• Adults aged between 16 and 110

• Admitted to hospital (Oxford University Hospitals NHS Foundation Trust) or attended the emergency department between 1/10/2021 to 31/8/2023

Exclusion Criteria:

Both retrospective and prospective cohorts:

• Patients who inform us directly that they do not wish their records used in this research study

• Patients who have completed the NHS Opt-out.

Related Conditions & MeSH terms

• Gastro Intestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage
• Trauma

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust (John Radcliffe Hospital)	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Oxford University Hospitals NHS Trust, University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of patients identified who consent for their blood samples to be retained and analysed as a percentage of those correctly identified as having suffered bleeding by the REBLEED system.; An acceptable recruitment rate is defined as at least 20%, from a total of at least 200 patients correctly identified as having suffered bleeding by the REBLEED system.; Patients correctly identified as having suffered bleeding by the REBLEED system is defined as: Flagged by REBLEED system as potentially having suffered bleeding AND confirmed as having suffered bleeding by research nurse review of electronic medical records	Within 3 months from start of recruitment