Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000650190
Ethics application status
Approved
Date submitted
23/04/2019
Date registered
1/05/2019
Date last updated
13/10/2021
Date data sharing statement initially provided
1/05/2019
Date results information initially provided
13/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of an immediate pre-operative haemoglobin blood test on hip fracture patient outcomes: A before and after cohort study
Scientific title
The effect of an immediate Pre-OPerative haemoglobin blood test on hip fracture patient outcomes: A before and after cohort study
Secondary ID [1] 298030 0
Nil Known
Universal Trial Number (UTN)
U1111-1232-1081
Trial acronym
POP test
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hip fracture 312484 0
anaemia 312485 0
femur fracture 312486 0
post-operative complications 312488 0
Condition category
Condition code
Anaesthesiology 311029 311029 0 0
Other anaesthesiology
Surgery 311030 311030 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Currently, a pre-operative Haemoglobin (Hb) level check is only performed in patients with hip fracture on admission to the Emergency Department approximately 16-48hours before surgery. Other studies have identified that the majority of blood loss a hip fracture patient experiences happens prior to surgery. Participants will be recruited into two groups; Retrospective group and Prospective group. The retrospective group will have received care according to the hospitals hip fracture care pathway which guides only 1 pre-operative Hb level check is required to be performed on admission to the Emergency Department. The prospective group will have an additional Hb test using a point-of-care (HemoCue®) device immediately prior to surgery. The test may indicate acute fracture related pre-operative blood loss and/or diagnose anaemia. Treatment for anaemia such as; blood products, iron transfusion, oral midodrine, intravenous tranexamic acid, a change in the type of anaesthetic used or a delay in surgery may be provided to the patient at the anaesthetists discretion to prevent patient deterioration or minimise the risk of complications relating to blood loss/anaemia.
Intervention code [1] 314260 0
Diagnosis / Prognosis
Intervention code [2] 314261 0
Early detection / Screening
Intervention code [3] 314303 0
Treatment: Other
Comparator / control treatment
The retrospective group cohort will form the comparison. A Theatre Management System (TMS) report will identify the previous 300 patients having surgery for a hip fracture in reverse chronological order from the start date of prospective recruitment. We estimate the retrospective groups admission time period will be from February 2016-April 2017 based on the amount of hip fracture patients that the hospital has previously admitted. The TMS report will also be able to filter out patients who do not meet the inclusion criteria.
Control group
Historical

Outcomes
Primary outcome [1] 319832 0
Acute Hospital Length of Stay (LOS)
Timepoint [1] 319832 0
LOS will be assessed by review of medical records and by utilising a patient tracking health program called webPAS (the web based Patient Administration System).
Secondary outcome [1] 369620 0
Treatment decisions made by the anaesthetist and surgeon peri-operatively; Use of blood product transfusions intra-operatively, use of TXA, use of iron transfusions, use of pre-operative or post-operative midodrine, number of serum Hb blood tests requested intra-operatively and post-operatively, type of anaesthetic used (spinal/regional vs general anaesthetic), the decision made by the Consultant to operate as the primary surgeon and the decision to delay or post-pone time of surgery. The Anaesthetic Record (medical record) and the theatre management system will be used to identify what treatments are provided to each participant.
Timepoint [1] 369620 0
All treatments provided to the patient from arrival to the theatre department to departure from the post-anaesthetic care unit.
Secondary outcome [2] 369621 0
Mortality
Timepoint [2] 369621 0
Mortality will be assessed at hospital discharge and at 30 days, 90 days and 1 year from the day of surgery, Mortality will be collected using the program iSoft Clinical Manager.
Secondary outcome [3] 369623 0
Whether an HDU or ICU admission is required for post-operative care
Timepoint [3] 369623 0
The discharge location at time of departure from the post-anaesthetic care unit (PACU). This data will be collected using the Theatre Management System.
Secondary outcome [4] 369625 0
PACU LOS
Timepoint [4] 369625 0
The clinical time (in minutes) a participant spends in the PACU, from arrival to the time the participant meets the PACU discharge to ward criteria. Both the theatre management system records these time points and will be used to collect this data.

Eligibility
Key inclusion criteria
• Patients with a low impact hip fracture requiring surgical intervention
• Adults aged >50years
• Patients able to consent to participate in the research study
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Elective surgery
• Hip fracture surgery to repair/replace fractures of pre-existing prosthesis or metal work
• Jehovah’s Witnesses/ Patients refusing treatment for low Hb
• Complicated fractures caused by cancer, metastases or tumour of the femur
• 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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Only prospective participants will receive an interventional immediate pre-operative Hb test. Retrospective participants will not have received this test as it is not a part of the routine hip fracture care pathway.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multivariate linear regression will be used to compare the hospital LOS and PACU LOS between the three groups. Multivariate logistic regression will compare dichotomous outcomes (intra-operative and post-operative blood and iron transfusion, formal Hb requests etc.) All analyses will make adjustments for potential effect modifiers and confounders of age, gender, age*gender interaction, ASA score, patient comorbidity, ED admission Hb, use of tranexamic acid, use of pre-operative anticoagulants and antiplatelet medication, and pre-operative INR. An additional reliability test will be performed using the HemoCue® results and any formal Hb test results requested to confirm HemoCue® readings. We will test the reliability of HemoCue® machines using a Bland Altman plot analysis.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
23/04/2018
Date of last participant enrolment
Anticipated
23/10/2019
Actual
19/09/2019
Date of last data collection
Anticipated
23/10/2020
Actual
12/03/2020
Sample size
Target
600
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13648 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 26324 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 302558 0
Other Collaborative groups
Name [1] 302558 0
The Sir Charles Gairdner Hospital and Osborne Park Hospital Research Advisory Council
Country [1] 302558 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Sir Charles Gairdner Hospital,
Hospital Avenue
2nd Floor A Block (Mailbox 26)
Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 302465 0
University
Name [1] 302465 0
Edith Cowan University
Address [1] 302465 0
270 Joondalup Dr, Joondalup WA 6027
Country [1] 302465 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303202 0
Sir Charles Gairdner and Osborne Park Health Care Group HREC
Ethics committee address [1] 303202 0
Sir Charles Gairdner Hospital
Hospital Avenue, 2nd Floor A Block (Mailbox 26)
Nedlands, WA, 6009
Ethics committee country [1] 303202 0
Australia
Date submitted for ethics approval [1] 303202 0
13/11/2017
Approval date [1] 303202 0
10/04/2018
Ethics approval number [1] 303202 0
RGS0000000688
Ethics committee name [2] 303203 0
Edith Cowan University HREC
Ethics committee address [2] 303203 0
270 Joondalup Dr, Joondalup WA 6027
Ethics committee country [2] 303203 0
Australia
Date submitted for ethics approval [2] 303203 0
10/04/2018
Approval date [2] 303203 0
19/04/2019
Ethics approval number [2] 303203 0
20514

Summary
Brief summary
In patients with hip fracture, low haemoglobin (Hb) levels are associated with post-operative complications, mortality, and increased hospital Length of Stay (LOS). A pre-operative Hb is taken on admission to the Emergency Department at Sir Charles Gairdner Hospital (SCGH). At the time of surgery, admission Hb levels may not be reliable indicators of current patient Hb status due to continual acute fracture-related blood loss, haemo-concentration and delays to surgery. This cohort study will investigate if an intervention of an Hb test immediately before surgery will improve patient outcomes. We will compare outcomes between 300 prospective patients and 300 retrospective patients. The outcome measures include hospital LOS, use of blood transfusions, Post-Anaesthetic Care Unit LOS, post-operative complications, admission to critical care areas, and survival to discharge. We foresee the results of this study may improve patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92838 0
Miss Peri Mickle
Address 92838 0
Department of Anaesthesia, SCGH
Level 1 G Block
Hospital Avenue, Nedlands, 6009
WA
Country 92838 0
Australia
Phone 92838 0
+61 8 6457 7220
Fax 92838 0
Email 92838 0
[email protected]
Contact person for public queries
Name 92839 0
Miss Peri Mickle
Address 92839 0
Department of Anaesthesia, SCGH
Level 1 G Block
Hospital Avenue, Nedlands, 6009
WA
Country 92839 0
Australia
Phone 92839 0
+61 8 6457 7220
Fax 92839 0
Email 92839 0
[email protected]
Contact person for scientific queries
Name 92840 0
Miss Peri Mickle
Address 92840 0
Department of Anaesthesia, SCGH
Level 1 G Block
Hospital Avenue, Nedlands, 6009
WA
Country 92840 0
Australia
Phone 92840 0
+61 8 6457 7220
Fax 92840 0
Email 92840 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
protect the confidentiality and privacy of participants


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.