Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000821796
Ethics application status
Approved
Date submitted
2/06/2022
Date registered
10/06/2022
Date last updated
10/06/2022
Date data sharing statement initially provided
10/06/2022
Date results provided
10/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Frailty predicts mortality in patients with upper gastrointestinal bleed: A single centre observational study.
Scientific title
Frailty predicts mortality in patients with Upper Gastrointestinal bleed: A prospective cohort study
Secondary ID [1] 306998 0
None
Universal Trial Number (UTN)
U1111-1277-6243
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
upper gastrointestinal bleed 326116 0
Frailty 326529 0
Condition category
Condition code
Oral and Gastrointestinal 323439 323439 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
21
Target follow-up type
Months
Description of intervention(s) / exposure
Assessing the role of frailty as measured by the Canadian Study of Health and Ageing (CSHA) clinical frailty scale, age, and other risk scores (Charles comorbidity index, Glasgow Blatchford score, AIMS 65 score) in predicting mortality in consecutive patients with upper gastrointestinal bleed over 21 months.
The score of frailty is assigned by an investigator at the time of upper GI bleed from an overall clinical assessment after their informed consent. The rest of the data is collected from the medical records. The 30-day follow-up data is either obtained from the medical records if available or via telephone follow-up.
Intervention code [1] 323442 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331176 0
Inpatient mortality. The data is obtained via electronic medical records.
Timepoint [1] 331176 0
Mortality during their inpatient stay, which is obtained from patient's electronic medical records.
Secondary outcome [1] 409093 0
30-day mortality
Timepoint [1] 409093 0
30 days after upper gastrointestinal bleed. The data is collected from electronic medical records.
Secondary outcome [2] 410514 0
30-day rebleed
Timepoint [2] 410514 0
30 days after their upper gastrointestinal bleed. The data is collected from electronic medical records.
Secondary outcome [3] 410515 0
30-day readmission
Timepoint [3] 410515 0
30 days after their upper gastrointestinal bleed. The data is collected from electronic medical records.
Secondary outcome [4] 410516 0
red blood cell transfusion
Timepoint [4] 410516 0
from the day of upper gastrointestinal bleed for patients who are already inpatient OR from the day of ED presentations who present to ED until the day of their discharge. The data is collected from electronic medical records.
Secondary outcome [5] 410517 0
intensive car unit admission
Timepoint [5] 410517 0
from the day of upper gastrointestinal bleed for patients who are already inpatient OR from the day of ED presentations who present to ED until the day of their discharge. The data is collected from electronic medical records.
Secondary outcome [6] 410518 0
endoscopic re-intervention
Timepoint [6] 410518 0
during their inpatient stay or within 30-days from their index upper gastrointestinal bleed if they are discharged prior to 30-days. The data is collected from electronic medical records.
Secondary outcome [7] 410519 0
hospital length of stay
Timepoint [7] 410519 0
from the day of upper gastrointestinal bleed for patients who are already inpatient OR from the day of ED presentations who present to ED until the day of their discharge.
The data is collected from electronic medical records.

Eligibility
Key inclusion criteria
Age > or = 18 years
Informed consent
Symptoms of Upper gastrointestinal bleed (malaena, haematemesis, coffee-ground emesis, Haematochezia)
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years and >100 years
no informed consent
Lower Gastrointestinal bleed on endoscopic assessment
Bleeding without any source on endoscopic assessment
No bleeding on endoscopic assessment

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Univariate and multivariate analyses were conducted on the variables to determine whether they predict all-cause inpatient mortality.
The same analysis was also done on the age and other risk scores to determine whether they predict 30-day all-cause mortality, 30-day re-bleed, 30-day re-admission, ICU admission, need for blood transfusion, endoscopic re-intervention, and hospital length of stay.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/10/2015
Date of last participant enrolment
Anticipated
Actual
29/06/2017
Date of last data collection
Anticipated
Actual
6/07/2017
Sample size
Target
229
Accrual to date
Final
229
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22248 0
Liverpool Hospital Gastro and Liver Services - Liverpool
Recruitment postcode(s) [1] 37412 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 311310 0
Hospital
Name [1] 311310 0
Liverpool Hospital
Country [1] 311310 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
75 Elizabeth St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 312674 0
None
Name [1] 312674 0
Address [1] 312674 0
Country [1] 312674 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310812 0
Southwestern Sydney Local Health District Ethics committee
Ethics committee address [1] 310812 0
Ethics committee country [1] 310812 0
Australia
Date submitted for ethics approval [1] 310812 0
18/05/2015
Approval date [1] 310812 0
19/05/2015
Ethics approval number [1] 310812 0
2019/ETH04645

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118954 0
Dr Milan Bassan
Address 118954 0
Department of Gastroenterology and hepatology, Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 118954 0
Australia
Phone 118954 0
+61426255466
Fax 118954 0
Email 118954 0
[email protected]
Contact person for public queries
Name 118955 0
Mohammed Affan Guliyara
Address 118955 0
Department of Gastroenterology and hepatology, Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 118955 0
Australia
Phone 118955 0
+61426255466
Fax 118955 0
Email 118955 0
[email protected]
Contact person for scientific queries
Name 118956 0
Mohammed Affan Guliyara
Address 118956 0
Department of Gastroenterology and hepatology, Liverpool Hospital
75 Elizabeth St, Liverpool NSW 2170
Country 118956 0
Australia
Phone 118956 0
+61426255466
Fax 118956 0
Email 118956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
underlying published results only
When will data be available (start and end dates)?
Beginning 3 months following main results publication; no end date determined
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator. The contact details: +61426255466 or [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFrailty predicts mortality in patients with upper gastrointestinal bleed: a prospective cohort study.2023https://dx.doi.org/10.1111/jgh.16188
N.B. These documents automatically identified may not have been verified by the study sponsor.