Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000160134
Ethics application status
Not required
Date submitted
22/01/2019
Date registered
4/02/2019
Date last updated
4/02/2019
Date data sharing statement initially provided
4/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Blunt chest trauma risk stratification score validation study
Scientific title
Retrospective validation of a risk stratification tool developed for management of patients with blunt chest trauma.
Secondary ID [1] 297174 0
Nil Known
Universal Trial Number (UTN)
U1111-1227-2530
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
trauma 311215 0
Thoracic complications 311216 0
Condition category
Condition code
Emergency medicine 309842 309842 0 0
Other emergency care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study looking at patients presenting with thoracic blunt trauma. Data regarding all complications felt to be due to the blunt trauma will be recorded. Data will be used to inform on a trauma risk stratification score, that will be retrospectively validated.
Data during the initial presentation, as well as any subsequent presentation to secondary or tertiary care, deemed to be due to a complication of the initial trauma, will be recorded and utilised.
No participant involvement is required due to the retrospective nature of the study and the ulitsation of normal health care records collected by the hospitals.
Intervention code [1] 313437 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318797 0
All complications of blunt chest trauma, defined by Battle et al. (Critical Care 2014, 18:R98), assessed by medical record audit.
Timepoint [1] 318797 0
At time of discharge from hospital, which may be from ED or from an inpatient ward.
Secondary outcome [1] 366067 0
Predicted outcome of blunt chest trauma at arrival to ED (early complications) as assessed by the prognostic model of Battle et al. (Critical Care 2014, 18:R98)
Timepoint [1] 366067 0
At time of discharge from ED to the ward or community.
Secondary outcome [2] 366354 0
Delayed complications of blunt trauma as defined by Battle et al. (Critical Care 2014, 18:R98) (e.g. delayed pulmonary complications, escalation in care, re-presentation to the ED) as assessed by medical record audit.
Timepoint [2] 366354 0
72 hours after discharge from ED

Eligibility
Key inclusion criteria
• Male or Female, aged 18 years or above. No upper age limit has been set.
• Patients who have presented with a primary diagnosis of blunt chest trauma.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with penetrating chest trauma
• Patients presenting with any immediate life-threatening injuries
• Patients with multi-trauma defined as any concurrent injuries, in addition to chest trauma, that will significantly determine the patient’s management

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistics appropriate to the underlying distributions will be used to show the baseline characteristics for continuous variables. Proportions with 95% CI will be used for categorical variables.

At each score break-point, the observed probability of any complications will be compared to the predicted probability at that point in the original article by Battle et al. using a Chi-test. The sensitivity and the specificity of the prognostic tool will be calculated and a ROC curve will be plotted using the sensitivity/ 1-specificity ratio. An area under the ROC curve will be calculated and compared to that reported in the Battle article (Critical Care 2014, 18:R98). This analysis will be carried out for the primary and secondary outcomes as described.

Similar areas under the ROC curve will be calculated for ethnicity subgroups to assess score validity for these groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
1/07/2019
Actual
Sample size
Target
500
Accrual to date
200
Final
Recruitment outside Australia
Country [1] 21222 0
New Zealand
State/province [1] 21222 0

Funding & Sponsors
Funding source category [1] 301725 0
Self funded/Unfunded
Name [1] 301725 0
Country [1] 301725 0
Primary sponsor type
Individual
Name
Saptarshi Mukerji
Address
Emergency Department
Capital and Coast District Health Board
Riddiford Street
Wellington
6021
Country
New Zealand
Secondary sponsor category [1] 301466 0
None
Name [1] 301466 0
NIl
Address [1] 301466 0
Country [1] 301466 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 302451 0
Ethics committee address [1] 302451 0
Ethics committee country [1] 302451 0
Date submitted for ethics approval [1] 302451 0
Approval date [1] 302451 0
Ethics approval number [1] 302451 0

Summary
Brief summary
A clinical score has been developed in UK emergency departments to predict the risk of complications after blunt chest wall trauma in patients without multi-trauma and those without immediate life-threatening injuries. The model comprises five risk factors: age, number of rib fractures, pre-existing chronic lung disease, use of preinjury anticoagulants and oxygen saturation on initial assessment in the ED. The patient is scored on each risk factor and the total score is used to guide the clinician in the ED as to whether the patient should be admitted to the ward, critical care unit or can be safely discharged home. However, this score requires validation in New Zealand.

The aim is to carry out a retrospective validation of the scoring system developed in the UK to provide an insight as to whether the score would be beneficial in New Zealand ED settings. In particular, we want to assess how the scoring system performs as a prognostic tool for all, early and late complications of chest wall trauma.
Trial website
Trial related presentations / publications
Public notes
Ethics- By HDEC's assessment of our study, there is no requirement for getting ethical approval. However, given that multiple sites will be involved and for the sake of GCP, we are going to apply for ethics sign off in first 2 weeks of February 2019.

Contacts
Principal investigator
Name 90262 0
Dr Saptarshi Mukerji
Address 90262 0
Emergency Department
Capital and Coast District Health Board
Riddiford Street
Wellington
6021
Country 90262 0
New Zealand
Phone 90262 0
+64 223128766
Fax 90262 0
Email 90262 0
[email protected]
Contact person for public queries
Name 90263 0
Dr Saptarshi Mukerji
Address 90263 0
Emergency Department
Capital and Coast District Health Board
Riddiford Street
Wellington
6021
Country 90263 0
New Zealand
Phone 90263 0
+64 223128766
Fax 90263 0
Email 90263 0
[email protected]
Contact person for scientific queries
Name 90264 0
Dr Saptarshi Mukerji
Address 90264 0
Emergency Department
Capital and Coast District Health Board
Riddiford Street
Wellington
6021
Country 90264 0
New Zealand
Phone 90264 0
+64 223128766
Fax 90264 0
Email 90264 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?
Raw data from all sites for each patient. Data will by annonymised.
When will data be available (start and end dates)?
Data will be made available at the time of publication of the study report. Date cannot be predicted but it is hoped by the end of 2019. No end date has been set by the investigators.
Available to whom?
Available to other accredited and legitimate investigator individuals and groups.
Available for what types of analyses?
Any
How or where can data be obtained?
On request by email to the principal investigator


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.