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

NCT05608577 | Completed

• 1 other identifier: PID15451
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage; Trauma; Gastro Intestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Retrospective

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

Eligibility Criteria

• Age: 16 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted to Oxford University Hospitals NHS Foundation Trust

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• University of Leicester: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust (John Radcliffe Hospital)

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Ethylenediamine tetraacetic acid (and citrate blood samples taken as part of routine clinical care)

MeSH Terms

Conditions

Hemorrhage; Wounds and Injuries; Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Peter Watkinson, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 8, 2022
• Study Start: October 1, 2021
• Primary Completion: February 18, 2026
• Study Completion: February 18, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)