HemorrhageRE-BLEEDNCT05608577
RE-BLEED: A Digital Platform for Identifying Bleeding Patients - a Feasibility Study
An observational study of Hemorrhage and Trauma, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 110 years
- Conditions the study is for
- Hemorrhage, Trauma, Gastro Intestinal Bleeding
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2021to 18 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult patients admitted to Oxford University Hospitals NHS Foundation Trust
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust (John Radcliffe Hospital)
Oxford, Oxfordshire, OX3 9DU
About this study
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.
Read the 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
- Medical subject headings
- Hemorrhage, Wounds and Injuries, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 3 months from start of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Oct 2021
- Primary completion18 Feb 2026
- Study completion18 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Peter Watkinson, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608577
- Sponsor's protocol ID
- PID15451
- Acronym
- RE-BLEED
- Status last verified
- Feb 2026
- First submitted
- 21 Oct 2022
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy and legal implications.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RE-BLEED: A Digital Platform for Identifying Bleeding Patients - a Feasibility Study
- ClinicalTrials.gov ID
- NCT05608577
- Acronym / sponsor ID
- RE-BLEED / PID15451
- Conditions
- Hemorrhage, Trauma, Gastro Intestinal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Leicester, Oxford University Hospitals NHS Trust
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 16 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult patients admitted to Oxford University Hospitals NHS Foundation Trust
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recruitment rate
Time frame: Within 3 months from start of recruitment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to privacy and legal implications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Watkinson, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Trauma, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Within 3 months from start of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.