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

NCT ID: NCT05608577

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-02-28

Brief 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.

Detailed 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.

Conditions

Hemorrhage; Trauma; Gastro Intestinal Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Retrospective

Up to 1,750,000 patient admissions (up to 10 years of admissions) from one National Health Service Trust (Hospital group)

No interventions assigned to this group

Prospective Hospital Cohort

Up to 87, 500 will be screened by the digital platform to identify those who may have bled during the recruitment period, of which at least 40 will be approached for their consent to retain their blood samples (collected as part of routine care).

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leicester

OTHER

Sponsor Role: collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Watkinson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Oxford University Hospitals NHS Foundation Trust (John Radcliffe Hospital)

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PID15451

Identifier Type: -

Identifier Source: org_study_id