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Oakland-Jairath Score Validation

NCT03935360 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 344

Last updated 2024-03-22

No results posted yet for this study

Summary

Lower gastrointestinal bleeding (LGIB) is a common presentation in the Emergency Room. It can deteriorate into severe adverse event. However some are discharged before these events occur. The Oakland-Jairath score was developed to help determine which patients can be safely discharged and which should be admitted from the ER to the hospital. The score did well in its development, but now needs to be externally validated by other independent cohorts. The limitations of the first study will be addressed in our study. The goal of this study is to perform the first prospective, multi-centered, external validation of the Oakland-Jairath risk score on an independent and diverse population who present to the emergency room with LGIB.

Conditions

  • Lower Gastrointestinal Bleeding

Interventions

OTHER

Oakland-Jairath Risk Score

Oakland and Jairath developed a clinical prediction rule for safe discharge among patients with LGIB using data from their UK National Audit. They defined safe discharge as the absence of rebleeding, blood transfusion, need for endoscopic/radiologic/surgical intervention for hemostasis, readmission with LGIB, and death and developed a seven variable risk score: age, sex, previous history of LGIB admission, presence of blood on digital rectal exam, heart rate, systolic blood pressure, and hemoglobin. Using a cut-off score ≤8, they reported excellent discrimination (AUC 0.84, 95% CI 0.82-0.86), good calibration, and a 95% probability of safe discharge.

Sponsors & Collaborators

  • Western University, Canada

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Michael Sey, MD · Lawson Research; Western University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2024-03-02
Completion
2024-03-02

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03935360 on ClinicalTrials.gov