Oakland-Jairath Score Validation

NCT03935360 | Completed

• 1 other identifier: 113116
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

lower gastrointestinal bleeding; external validation; prognostic risk score; safe discharge; multi-centre cohort study; obscure gastrointestinal bleeding; hospital presentation

Outcome Measures

Primary Outcomes (1)

• Discrimination of the Oakland-Jairath score for predicting safe discharge

  Discrimination, defined as the ability of the prediction model to differentiate between those who develop and do not develop the outcome event of interest, as measured by the c-statistic, and calibration, defined as the agreement between predicted and observed outcomes, measured by a calibration plot, of the Oakland-Jairath score for predicting safe discharge, defined as the absence of ALL of the following: i. Rebleeding, defined as \[additional blood transfusions\] or \[a further decrease in hematocrit concentration of 20% or more\], both after 24h clinical stability ii. Readmission for LGIB within 28 days iii. Red blood cell transfusion iv. Therapeutic intervention for hemostasis (endoscopic/IR/surgery) v. Death within 28 days

  28 days after enrollment

Secondary Outcomes (2)

• Discrimination of the Oakland-Jairath score compared to pre-existing LGIB risk scores

  28 days after enrollment

• Discrimination of the Oakland-Jairath score compared to traditional UGIB risk scores

  28 days after enrollment

Interventions

Oakland-Jairath Risk Score OTHER

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.

Eligibility Criteria

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

Study Population

Any adult person who presents with lower gastointestinal bleeding as defined by: bright red blood per rectum, and/or maroon coloured stool.

You may qualify if:

• \. Presenting complaint of LGIB, defined as any of the following:
• Bright red blood per rectum
• Maroon coloured stool
• Criteria A and B applies regardless if the blood is seen without stool, with stool of any consistency, or only on the toilet paper

You may not qualify if:

• Age ≤ 18
• Hematemesis, defined as bright blood or coffee ground emesis
• Patients who developed LGIB while already admitted to hospital for any reason
• Patients transferred between hospitals
• Failure to obtain informed consent
• Occult bleeding, defined as the presence of a positive FOBT/FIT or iron deficiency anemia in the absence of bright red blood per rectum or maroon coloured stool
• Perceived inability to contact the subject by telephone or e-mail for the 28 day follow up assessment

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator
• Université de Montréal: collaborator
• University of Alberta: collaborator
• McGill University: collaborator
• University of Oxford: collaborator

Study Sites (6)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Health Science Centre

Winnipeg, Manitoba, R3E 3P5, Canada

Location

Nova Scotia Health - Victoria General Site

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Study Officials

• Michael Sey, MD

  Lawson Research; Western University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 2, 2019
• Study Start: November 25, 2019
• Primary Completion: March 2, 2024
• Study Completion: March 2, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)