Lower Gastrointestinal BleedingNCT03935360
Oakland-Jairath Score Validation
An observational study of Lower Gastrointestinal Bleeding, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Gastrointestinal Bleeding
- What is being tested?
- Oakland-Jairath Risk Score
- How many people
- 344 participants
- Where
- 6 sitesCanada
- Study dates
- 25 Nov 2019to 2 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult person who presents with lower gastointestinal bleeding as defined by: bright red blood per rectum, and/or maroon coloured stool.
Who may be able to join
- 1. 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Nova Scotia Health - Victoria General Site
Halifax, Nova Scotia, B3H 2Y9
London Health Sciences Centre
London, Ontario, N6A 5W9
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Health Science Centre
Winnipeg, Manitoba, R3E 3P5
About this study
Official title: External Validation of a Prognostic Risk Score for Safe Discharge Among Patients With Lower Gastrointestinal Bleeding: A Prospective Multi-centre Cohort Study
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.
Read the detailed description
Of critical importance in the approach to care of these patients is differentiating the majority of people who can be safely discharged for outpatient management from those who are at risk for serious adverse events and require hospitalization. Recently, Oakland and Jairath developed a clinical prediction rule for safe discharge among patients with LGIB using data from their UK National Audit. The next step in the development of a clinical prediction rule is external validation in independent cohorts. Measures of predictive accuracy for risk scores, such as the AUC, are overly optimistic when calculated from the derivation cohort from which the risk score was derived. Therefore, it is essential to evaluate its performance using independent and diverse validation cohorts. Thus, 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. This is a prospective multi-centre observational study to externally validate the Oakland-Jairath LGIB risk score, herein referred to simply as the "risk score".
Consecutive patients presenting to hospital over a 6 month period will have their risk score calculated and followed for the development of an adverse outcome over a 28 day period. The risk score will be determined for research purposes only but will be shared with the treating physician if requested as the details of the risk score itself is within the public domain. Patients will be eligible regardless of discharge status and all admission decisions will be made solely by the treating physicians. To increase the diversity of the validation cohort, increase generalizability, and hasten recruitment, the study will be conducted at 4 centres: Western University, University of Alberta, University of Montreal, and McGill University.
- Conditions
- Lower Gastrointestinal Bleeding
- Being tested
- Oakland-Jairath Risk Score
- Keywords
- lower gastrointestinal bleeding, external validation, prognostic risk score, safe discharge, multi-centre cohort study, obscure gastrointestinal bleeding, hospital presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oakland-Jairath Risk ScoreOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: 28 days after enrollment
Secondary outcomes (2)
Discrimination of the Oakland-Jairath score compared to pre-existing LGIB risk scores
Measured by the c-statistic and compared using the DeLong test The scale is Oakland \& Jairath score for the prediction of safe discharge after LGIB. There are seven variables that are scored. Having a lower score in all variables and overall represents a better outcome for a safe discharge after LGIB.
Age: <40 = 0; 40-69 =1; ≥70 =2 Sex: F = 0; M =1 Previous LGIB admission: No = 0; Yes = 1 DRE findings: No blood = 0; Blood = 1 Heart rate (bpm): ≤70 = 0; 70-89= 1; 90-109= 2; ≥110 = 3 Systolic blood pressure (mmHg): 50-89 = 5; 90-119 = 4; 120-129 = 3; 130-159 = 2; ≥160 = 0 Hemoglobin (g/dL): 36-69 = 22; 70-89 = 17; 90-109 = 13; 110-129 = 8; 130-159 = 4; ≥160 = 0
Total with variables added together that translates to the probability of safe discharge:
0-2 = 0.99; 3 = 0.98; 4 = 0.97; 5-7 = 0.96; 8 = 0.95; 9 = 0.93; 10 = 0.91; 11 = 0.89; 12-13 = 0.87-0.89; 14-15 = 0.77-0.81; 16-17 = 0.67-0.72; 18-20 = 0.50-0.62; 21-23 = 0.33-0.45; 24-26 = 0.20-0.28; 27-29 = 0.11-0.16; ≥30 = <0.1
Measured: 28 days after enrollment
Discrimination of the Oakland-Jairath score compared to traditional UGIB risk scores
Measured by the c-statistic and compared using the DeLong test The scale is Oakland \& Jairath score for the prediction of safe discharge after LGIB. There are seven variables that are scored. Having a lower score in all variables and overall represents a better outcome for a safe discharge after LGIB.
Age: <40 = 0; 40-69 =1; ≥70 =2 Sex: F = 0; M =1 Previous LGIB admission: No = 0; Yes = 1 DRE findings: No blood = 0; Blood = 1 Heart rate (bpm): ≤70 = 0; 70-89= 1; 90-109= 2; ≥110 = 3 Systolic blood pressure (mmHg): 50-89 = 5; 90-119 = 4; 120-129 = 3; 130-159 = 2; ≥160 = 0 Hemoglobin (g/dL): 36-69 = 22; 70-89 = 17; 90-109 = 13; 110-129 = 8; 130-159 = 4; ≥160 = 0
Total with variables added together that translates to the probability of safe discharge:
0-2 = 0.99; 3 = 0.98; 4 = 0.97; 5-7 = 0.96; 8 = 0.95; 9 = 0.93; 10 = 0.91; 11 = 0.89; 12-13 = 0.87-0.89; 14-15 = 0.77-0.81; 16-17 = 0.67-0.72; 18-20 = 0.50-0.62; 21-23 = 0.33-0.45; 24-26 = 0.20-0.28; 27-29 = 0.11-0.16; ≥30 = <0.1
Measured: 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start25 Nov 2019
- Primary completion2 Mar 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Gastrointestinal BleedingStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada, Université de Montréal, University of Alberta, McGill University, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Michael Sey, MD, Principal investigator, Lawson Research; Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935360
- Sponsor's protocol ID
- 113116
- Status last verified
- Mar 2024
- First submitted
- 30 Apr 2019
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sey M, von Renteln D, Kohansal A, Veldhuyzen van Zanten S, Singh H, Edmonds M, Wiemer H, Zhou F, Pedicelli A, Keshlaf H, Archer M, Oakland K, Guizzetti L, Barkun A, Jairath V. A National Prospective Multicenter Comparison of Risk Scores Against Clinical Judgement for the Prediction of Safe Discharge From the Emergency Department in Patients Presenting With Lower Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2026 May 27:S1542-3565(26)00391-5. doi: 10.1016/j.cgh.2026.05.014. Online ahead of print.
PubMed 42208784
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of a Prognostic Risk Score for Safe Discharge Among Patients With Lower Gastrointestinal Bleeding: A Prospective Multi-centre Cohort Study
- ClinicalTrials.gov ID
- NCT03935360
- Acronym / sponsor ID
- 113116
- Conditions
- Lower Gastrointestinal Bleeding
- Keywords
- lower gastrointestinal bleeding, external validation, prognostic risk score, safe discharge, multi-centre cohort study, obscure gastrointestinal bleeding, hospital presentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Western University, Canada, Université de Montréal, University of Alberta, McGill University, University of Oxford
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 2 May 2019 (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.
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.
Detailed description
Of critical importance in the approach to care of these patients is differentiating the majority of people who can be safely discharged for outpatient management from those who are at risk for serious adverse events and require hospitalization. Recently, Oakland and Jairath developed a clinical prediction rule for safe discharge among patients with LGIB using data from their UK National Audit. The next step in the development of a clinical prediction rule is external validation in independent cohorts. Measures of predictive accuracy for risk scores, such as the AUC, are overly optimistic when calculated from the derivation cohort from which the risk score was derived. Therefore, it is essential to evaluate its performance using independent and diverse validation cohorts. Thus, 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. This is a prospective multi-centre observational study to externally validate the Oakland-Jairath LGIB risk score, herein referred to simply as the "risk score".
Consecutive patients presenting to hospital over a 6 month period will have their risk score calculated and followed for the development of an adverse outcome over a 28 day period. The risk score will be determined for research purposes only but will be shared with the treating physician if requested as the details of the risk score itself is within the public domain. Patients will be eligible regardless of discharge status and all admission decisions will be made solely by the treating physicians. To increase the diversity of the validation cohort, increase generalizability, and hasten recruitment, the study will be conducted at 4 centres: Western University, University of Alberta, University of Montreal, and McGill University.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult person who presents with lower gastointestinal bleeding as defined by: bright red blood per rectum, and/or maroon coloured stool.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oakland-Jairath Risk ScoreOakland 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. | Other | – |
Primary outcome
Discrimination of the Oakland-Jairath score for predicting safe discharge
Time frame: 28 days after enrollment
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
2 secondary outcomes
Discrimination of the Oakland-Jairath score compared to pre-existing LGIB risk scores
Time frame: 28 days after enrollment
Discrimination of the Oakland-Jairath score compared to traditional UGIB risk scores
Time frame: 28 days after enrollment
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 22 Mar 2024.
- Derived from this study: PubMed 42208784Sey M, von Renteln D, Kohansal A, Veldhuyzen van Zanten S, Singh H, Edmonds M, Wiemer H, Zhou F, Pedicelli A, Keshlaf H, Archer M, Oakland K, Guizzetti L, Barkun A, Jairath V. A National Prospective Multicenter Comparison of Risk Scores Against Clinical Judgement for the Prediction of Safe Discharge From the Emergency Department in Patients Presenting With Lower Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2026 May 27:S1542-3565(26)00391-5. doi: 10.1016/j.cgh.2026.05.014. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Michael Sey, MD principal investigator
Lawson Research; Western University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Gastrointestinal Bleeding, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 6 sites in Canada.
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 4 inclusion and 7 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 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
Discrimination of the Oakland-Jairath score for predicting safe discharge (time frame: 28 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935360, which also lists 1 linked publication.
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 22 Mar 2024.