Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000962831
Ethics application status
Approved
Date submitted
24/05/2021
Date registered
23/07/2021
Date last updated
29/06/2022
Date data sharing statement initially provided
23/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute Management of Spinal Cord Injury
Scientific title
A retrospective observational clinical research of current practice in the acute assessment and intensive care management of traumatic spinal cord injury
Secondary ID [1] 304292 0
None
Universal Trial Number (UTN)
None
Trial acronym
AMOSCI
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 322024 0
Condition category
Condition code
Injuries and Accidents 319747 319747 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This retrospective observational cohort study will review the eligible participants' demographics, details of the injury and associated injuries, comorbidities, emergency, surgical and intensive care management including neurological assessment, blood pressure management, imaging results and operative management over the initial 7 days following acute traumatic spinal cord injury.
Intervention code [1] 320632 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327609 0
The lowest blood pressure measured in the first 24 hours from patient medical records documentation.
Timepoint [1] 327609 0
24 hours post injury
Primary outcome [2] 327883 0
A composite primary outcome. The timing of the initial neurological examination and the proportion of participants that have a complete International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination within 72 hours of initial hospital admission from patient medical records documentation.
Timepoint [2] 327883 0
72 hours post injury
Primary outcome [3] 327884 0
A composite primary outcome. The average blood pressure (MAP and SBP in mmHg) measured over 7 days following the injury from patient medical records documentation.
Timepoint [3] 327884 0
7 days post injury
Secondary outcome [1] 395940 0
The proportion of patients admitted to the ICU from patient medical records documentation.
Timepoint [1] 395940 0
24 hours, 72 hours and 7 days post injury
Secondary outcome [2] 397845 0
The proportion of patients receiving vasopressor support from patient medical records documentation.
Timepoint [2] 397845 0
24 hours, 72 hours and 7 days post injury
Secondary outcome [3] 397846 0
The median duration of vasopressor support from patient medical records documentation,
Timepoint [3] 397846 0
24 hours, 72 hours and 7 days post injury
Secondary outcome [4] 397847 0
The median duration of ICU from patient medical records documentation.
Timepoint [4] 397847 0
24 hours, 72 hours and 7 days post injury
Secondary outcome [5] 397848 0
The incidence of complication rate of vasopressor treatment from patient medical records documentation.
Timepoint [5] 397848 0
24 hours, 72 hours and 7 days post injury
Secondary outcome [6] 398687 0
The median hospital length of stay from patient medical records documentation.
Timepoint [6] 398687 0
24 hours, 72 hours and 7 days post injury

Eligibility
Key inclusion criteria
Adult patients (>=16 years)
Admitted to participating Spinal Cord Injury Units
Between January 2018 and January 2020
Acute traumatic spinal cord injury as documented by ICD coding
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Transferred to participating spinal injury units more than 7 days following injury
Unable to access pre-hospital and ED records

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Baseline and process data will be summarised using means and standard deviations, median and interquartile range and counts and proportions as appropriate.
We will report the mean and standard deviation for the lowest recorded BP the first 24 hours, as well as the proportion of patients with a documented systolic blood pressure of < 90 mmHg.
Secondary outcomes will be expressed as a percentage, median duration, or incidence as required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
27/01/2022
Date of last data collection
Anticipated
31/12/2021
Actual
27/01/2022
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19521 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 19522 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 34120 0
2031 - Randwick
Recruitment postcode(s) [2] 34121 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 308666 0
Government body
Name [1] 308666 0
South Eastern Sydney Local Health District
Country [1] 308666 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney Local Health District
Address
District Executive Unit, Level4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah NSW 2229
Country
Australia
Secondary sponsor category [1] 309545 0
Government body
Name [1] 309545 0
Northern Sydney Local Health District
Address [1] 309545 0
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country [1] 309545 0
Australia
Other collaborator category [1] 281795 0
Other Collaborative groups
Name [1] 281795 0
Neuroscience Research Australia
Address [1] 281795 0
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [1] 281795 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308593 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 308593 0
SESLHD Research Support Office
Prince of Wales Hospital
Baker Street
Randwick NSW 2031
Ethics committee country [1] 308593 0
Australia
Date submitted for ethics approval [1] 308593 0
21/04/2021
Approval date [1] 308593 0
16/06/2021
Ethics approval number [1] 308593 0
2021/ETH00493

Summary
Brief summary
Spinal cord injury is devastating injury with significant functional and financial cost. Long term outcomes vary and depend on early injury factors and prevention of secondary neurological injury. This is a retrospective cohort study. The aim of this study is to identify current practice with reference to factors that influence prognostication and prevention of secondary neurological injury. These are early documentation of neurological status, and defence of blood pressure targets in keeping with international guidelines. Identifying current practice will facilitate design of future studies that aim to investigate long term outcomes. The primary objective of this study to describe current practice in the acute assessment and intensive care (ICU) management of spinal cord injury, with respect to timing and documentation of neurological status after injury, and acute blood pressure management in ICU.
Trial website
None
Trial related presentations / publications
None
Public notes
This retrospective observational study will be conducted in compliance with all stipulations of this protocol, the conditions of ethics committee approval, the NHMRC National Statement on Ethical Conduct in Human Research (2007) and the Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95).

Contacts
Principal investigator
Name 111258 0
Dr Tessa Garside
Address 111258 0
Intensive Care Unit
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country 111258 0
Australia
Phone 111258 0
+61 02 9926 7111
Fax 111258 0
None
Email 111258 0
[email protected]
Contact person for public queries
Name 111259 0
Trent Li
Address 111259 0
Department of Orthopaedic Surgery
Level 2 South Wing Edmund Blacket Building
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Country 111259 0
Australia
Phone 111259 0
+61 02 9382 2490
Fax 111259 0
+61 02 9382 2889
Email 111259 0
[email protected]
Contact person for scientific queries
Name 111260 0
Tessa Garside
Address 111260 0
Intensive Care Unit
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country 111260 0
Australia
Phone 111260 0
+61 02 9926 7111
Fax 111260 0
None
Email 111260 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.