Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001645347
Ethics application status
Approved
Date submitted
30/11/2017
Date registered
19/12/2017
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Date results provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Red blood cell transfusion, lowest haemoglobin level, and their association with mortality and length of hospital stay in surgical patients.
Scientific title
Associations of red blood cell transfusion and nadir haemoglobin with mortality and length of stay in surgical patients
Secondary ID [1] 293371 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Red blood cell transfusion 305494 0
Anaemia 305495 0
Condition category
Condition code
Blood 304746 304746 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
1) Presence of a red blood cell transfusion. This will be measured at any time during the patient’s hospital admission. 2) Level of nadir haemoglobin (in grams per litre). This will be the pre-transfusion haemoglobin or nadir haemoglobin in those not transfused.
Intervention code [1] 299626 0
Not applicable
Comparator / control treatment
Patients not receiving a red blood cell transfusion. This will be compared across different levels of nadir haemoglobin.
Control group
Active

Outcomes
Primary outcome [1] 303963 0
30-day mortality
Timepoint [1] 303963 0
30 days from admission
Primary outcome [2] 303964 0
In-hospital mortality
Timepoint [2] 303964 0
At time of hospital discharge.
Primary outcome [3] 303966 0
Hospital length of stay (measured in days). This outcomes is assessed by collecting the admission date and the discharge date from the admissions data collected.
Timepoint [3] 303966 0
From hospital admission to discharge.
Secondary outcome [1] 340544 0
Nil
Timepoint [1] 340544 0
Nil

Eligibility
Key inclusion criteria
Adults admitted as elective or emergency cases for orthopaedic surgery, gastrointestinal surgery, vascular surgery, urology, cardiothoracic surgery, or neurosurgery to three public hospitals in Western Australia between July 2008 and June 2017.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patients transfused fresh frozen plasma, platelets, and cryoprecipitate will be excluded from the study. Also excluded are patients receiving a massive transfusion, patients transfused any blood products 90 days prior to admission, patients with a length of stay of less than 2 days (same day and overnight admissions), patients under the age of 18 years at admission, and patients with no haemoglobin results.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Exposure and outcome variables will initially be described by univariate and bivariate statistics, the latter using the chi-squared test for categorical variables and independent samples t-test for continuous variables. Logistic regression models will be applied to test the relationship that both red blood cell transfusion and nadir haemoglobin levels have with in-hospital mortality and 30-day mortality. A zero-truncated negative binomial regression model will be applied to the length of stay outcome. All regression models will adjust for the same potential confounders. A robust variance adjustment will be applied to the regression models to account for any potential correlation between multiple admissions for the same patient.

For this analysis we are also interested in whether the presence of a red blood cell transfusion modifies the effect of nadir haemoglobin on in-hospital mortality, 30-day mortality and length of stay. To test any effect modification on outcome an interaction term between nadir haemoglobin level and red blood cell transfusion will be added to the multivariable logistic regression models. Only significant interactions (defined as p-values <0.05) will be reported, with calculated odds ratios for interaction terms presented.
In addition, Kaplan-Meier curves and Cox proportional hazards models will be plotted to show time to death in patients transfused red blood cells when compared to patients not transfused red blood cells across the various nadir haemoglobin levels.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/12/2017
Actual
12/02/2018
Date of last participant enrolment
Anticipated
21/12/2017
Actual
12/02/2018
Date of last data collection
Anticipated
21/12/2017
Actual
12/02/2018
Sample size
Target
60000
Accrual to date
Final
60955
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9399 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 9400 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 9401 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 18099 0
6150 - Murdoch
Recruitment postcode(s) [2] 18100 0
6000 - Perth
Recruitment postcode(s) [3] 18101 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 298253 0
Hospital
Name [1] 298253 0
Royal Perth Hospital
Country [1] 298253 0
Australia
Funding source category [2] 298264 0
University
Name [2] 298264 0
University of Western Australia
Country [2] 298264 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
197 Wellington St, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 297060 0
None
Name [1] 297060 0
Address [1] 297060 0
Country [1] 297060 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299033 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 299033 0
Ethics committee country [1] 299033 0
Australia
Date submitted for ethics approval [1] 299033 0
11/10/2017
Approval date [1] 299033 0
10/11/2017
Ethics approval number [1] 299033 0
RGS0000000415

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2234 2234 0 0
/AnzctrAttachments/374000-Research Protocol.pdf (Protocol)

Contacts
Principal investigator
Name 79058 0
Mr Kevin Trentino
Address 79058 0
Royal Perth Hospital,
197 Wellington St, Perth WA 6000
Country 79058 0
Australia
Phone 79058 0
+61 8 6477 5110
Fax 79058 0
Email 79058 0
[email protected]
Contact person for public queries
Name 79059 0
Michael Leahy
Address 79059 0
Royal Perth Hospital,
197 Wellington St, Perth WA 6000
Country 79059 0
Australia
Phone 79059 0
+61 8 9224 2405
Fax 79059 0
Email 79059 0
[email protected]
Contact person for scientific queries
Name 79060 0
Kevin Trentino
Address 79060 0
Royal Perth Hospital,
197 Wellington St, Perth WA 6000
Country 79060 0
Australia
Phone 79060 0
+61 8 6477 5110
Fax 79060 0
Email 79060 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


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.