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| Name | Class |
|---|---|
| University of Leicester | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Retrospective cohort:
Prospective cohort:
Exclusion Criteria:
Both retrospective and prospective cohorts:
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All adult patients admitted to Oxford University Hospitals NHS Foundation Trust
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| Name | Affiliation | Role |
|---|---|---|
| Peter Watkinson, MD | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Foundation Trust (John Radcliffe Hospital) | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
Individual participant data will not be made publicly available due to privacy and legal implications.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2022 | Oct 31, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Ethylenediamine tetraacetic acid (and citrate blood samples taken as part of routine clinical care)