Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000654358
Ethics application status
Approved
Date submitted
13/04/2017
Date registered
5/05/2017
Date last updated
16/03/2020
Date data sharing statement initially provided
16/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective validation study of the Glasgow-Blatchford score
Scientific title
The utility of the Glasgow-Blatchford score in predicting clinical outcome and stratifying the need for therapeutic intervention in hospitalised patients with upper gastrointestinal bleeding: a prospective validating study.
Secondary ID [1] 291577 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper Gastrointestinal Bleeding 302684 0
Condition category
Condition code
Oral and Gastrointestinal 302197 302197 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective validation study of the Glasgow-Blatchford Score

The Gastroenterology and Emergency Department (ED) will be informed of the proposed research project, in the form of an oral presentation by the Principal Investigators. Both departments will identify patients presenting with upper gastrointestinal bleeding in ED. In order to facilitate their decision making, potential participants will be given a patient information sheet and consent form. Flyers have been placed around ED for awareness of the study in the department. Patients who meet the inclusion criteria, either in the Emergency Department or on the wards, will be invited to participate in the study via telephone. After being consented with the consent form, those patients with a Glasgow-Blatchford Score (GBS) of three or less will be discharged, and an outpatient endoscopy within 2 weeks will be performed. If patients have a GBS of greater than 3, they will be admitted to the Royal Adelaide Hospital and an endoscopy will be performed at the hospital within 24 hours. In both cases, if therapeutic intervention is required, this treatment will also be carried out. Patients will also receive one long term follow up phone call.
Intervention code [1] 297639 0
Treatment: Other
Intervention code [2] 297969 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301703 0
Primary outcomes: In patients with a GBS of three or less;
The need for earlier hospital re-admission before the pre-arranged outpatient endoscopy within two weeks.
This outcome will be assessed by reviewing hospital records to check for re-admission.
Timepoint [1] 301703 0
Primary outcomes: In patients with a GBS of three or less;
This outcome is assessed two weeks post *initial* hospital admission.
Primary outcome [2] 301957 0
Primary outcomes: In patients with a GBS of three or less;
The need for earlier endoscopy before the pre-arranged outpatient endoscopy within two weeks.
This outcome will be assessed by reviewing hospital records to check for earlier endoscopy.
Timepoint [2] 301957 0
Primary outcomes: In patients with a GBS of three or less;
This outcome is assessed two weeks post *initial* hospital admission.
Secondary outcome [1] 333620 0
Secondary outcomes: In patients with a GBS of three or less;
1) The need for blood transfusion within two weeks.
This outcome is assessed by reviewing medical records and lab results.
Timepoint [1] 333620 0
Secondary outcomes: In patients with a GBS of three or less;
1) The need for blood transfusion for the patient is assessed within two weeks.
Secondary outcome [2] 334362 0
Secondary outcomes: In patients with a GBS of three or less;
1) The need for endotherapy within two weeks.
This outcome is assessed by reviewing medical records and lab results.
Timepoint [2] 334362 0
Secondary outcomes: In patients with a GBS of three or less;
1) The need for endotherapy for the patient is assessed within two weeks.
Secondary outcome [3] 334363 0
Secondary outcomes: In patients with a GBS of three or less;
1) The need for surgery within two weeks.
This outcome is assessed by reviewing medical records and lab results.
Timepoint [3] 334363 0
Secondary outcomes: In patients with a GBS of three or less;
1) The need for surgery for the patient is assessed within two weeks.
Secondary outcome [4] 334448 0
Secondary outcomes: In patients with a GBS of three or less;
2) Need for hospital re-admission within the first three months.
This outcome is assessed by reviewing medical records.
Timepoint [4] 334448 0
Secondary outcomes: In patients with a GBS of three or less;
2) Need for hospital re-admission for the patient is assessed within three months.
Secondary outcome [5] 334449 0
Secondary outcomes: In patients with a GBS of three or less;
3) Rebleeding within the first three months.
This outcome is assessed by reviewing medical records.
Timepoint [5] 334449 0
Secondary outcomes: In patients with a GBS of three or less;
3) Rebleeding for the patient is assessed within three months.
Secondary outcome [6] 334450 0
Secondary outcomes: In patients with a GBS of three or less;
3) Mortality within the first three months.
This outcome is assessed by reviewing medical records.
Timepoint [6] 334450 0
Secondary outcomes: In patients with a GBS of three or less;
3) Mortality for the patient is assessed within three months.

Eligibility
Key inclusion criteria
Two groups of hospitalised patients, aged greater than or equal to 18 years, who present to, or at, the Royal Adelaide Hospital for the management of UGIH. The first group of patients will be those presenting to the ED with a primary diagnosis of UGIH. The second group of patients will be inpatients who develop an UGIH during their admission at the Royal Adelaide Hospital. UGIH is defined as bleeding from the upper gastrointestinal tract as manifested by haematemesis (including coffee-ground vomiting) and/or melaena. Both variceal and non-variceal causes of UGIH will be included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients who are unable to give informed consent, and without the presence of a next of kin upon admission.
2) Patients with urgent medical comorbidities, other than UGIH, which require inpatient admission.
3) A known pre-existing cause of UGIH.
4) Patients in whom outpatient follow-up cannot be guaranteed, including:
a) Persons of no fixed address
b) Rural and remote patients (only secondary outcomes can be measured, given that all patients in this category will be admitted)
c) Patients with cognitive impairment
d) Patients who live alone with inadequate adult supervision or social supports
5) Pregnancy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/04/2015
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
400
Accrual to date
203
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 296146 0
Hospital
Name [1] 296146 0
Royal Adelaide Hospital
Country [1] 296146 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Department of Gastroenterology, Level 7, North Wing, Royal Adelaide Hospital, North Terrace, Adelaide, 5000, South Australia, Australia
Country
Australia
Secondary sponsor category [1] 295261 0
None
Name [1] 295261 0
Address [1] 295261 0
Country [1] 295261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297321 0
CALHN Human Research Ethics Committee
Ethics committee address [1] 297321 0
Ethics committee country [1] 297321 0
Australia
Date submitted for ethics approval [1] 297321 0
04/02/2015
Approval date [1] 297321 0
10/03/2015
Ethics approval number [1] 297321 0
HREC/15/RAH/28

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

Contacts
Principal investigator
Name 73698 0
A/Prof Nam Nguyen
Address 73698 0
Department of Gastroenterology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
South Australia, 5000
Country 73698 0
Australia
Phone 73698 0
+61 8 8222 5214
Fax 73698 0
Email 73698 0
[email protected]
Contact person for public queries
Name 73699 0
Nam Nguyen
Address 73699 0
Department of Gastroenterology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
South Australia, 5000
Country 73699 0
Australia
Phone 73699 0
+61 8 8222 5214
Fax 73699 0
Email 73699 0
[email protected]
Contact person for scientific queries
Name 73700 0
Nam Nguyen
Address 73700 0
Department of Gastroenterology,
Royal Adelaide Hospital,
Port Road,
Adelaide,
South Australia, 5000
Country 73700 0
Australia
Phone 73700 0
+61 8 8222 5214
Fax 73700 0
Email 73700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Any data that leaves the investigational site will be blinded and anonymized.


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
No additional documents have been identified.