Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000869279
Ethics application status
Approved
Date submitted
8/03/2018
Date registered
22/05/2018
Date last updated
29/06/2022
Date data sharing statement initially provided
11/02/2021
Date results information initially provided
29/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Demographic and clinical information in acute cervical spinal cord injury as part of the Riluzole in Spinal cord Injury Study (RISCIS)
Scientific title
Demographic and clinical information in acute cervical spinal cord injury as part of the Riluzole in Spinal cord Injury Study (RISCIS)
Secondary ID [1] 294284 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
NCT01597518: main RISCIS trial

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 306975 0
Condition category
Condition code
Injuries and Accidents 306070 306070 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
Investigators will analyse data collected for the RISCIS study on the demographics, spinal cord injury, neurological outcomes and quality of care of subjects presenting to participating hospitals. There will be no additional intervention involved. Period of follow-up will be the same as the main RISCIS protocol i.e., 12 months the longest.
The intervention is administered as part of the main RISCIS study and not in the study being registered in this form.
The primary objective of RISCIS is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury.
Experimental group: Riluzole.
Intervention code [1] 300581 0
Diagnosis / Prognosis
Comparator / control treatment
This is administered as part of the main RISCIS study and not in the study being registered in this form.
The primary objective of RISCIS is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury.
Placebo comparator: Placebo.
Control group
Active

Outcomes
Primary outcome [1] 305105 0
The composite primary outcome is the quality of care will be assessed by the time to review by a spinal rehabilitation physician, the occurrence of complications: DVT/PE, pneumonia, UTI and pressure area.
The primary outcome will be assessed by the review of medical records.
Timepoint [1] 305105 0
Post-injury/enrollment at baseline, 72-hours, 7-days, 14-days, 84-days, 180-days (primary endpoint) and 365-days.
Secondary outcome [1] 346585 0
ISNCSCI - ASIA Impairment Scale and motor score
Timepoint [1] 346585 0
Post-injury/enrollment at baseline, 72-hours, 7-days, 14-days, 84-days, 180-days (primary endpoint) and 365-days.
Secondary outcome [2] 346708 0
Onset and severity of pressure areas. (Composite secondary outcome)
This secondary outcome will be assessed by the review of medical record.
Timepoint [2] 346708 0
Post-injury/enrollment at baseline, 72-hours, 7-days, 14-days, 84-days, 180-days (primary endpoint) and 365-days.
Secondary outcome [3] 346709 0
Onset of pneumonia. The secondary outcome will be assessed by the review of medical record.
Timepoint [3] 346709 0
Post-injury/enrollment at baseline, 72-hours, 7-days, 14-days, 84-days, 180-days (primary endpoint) and 365-days.
Secondary outcome [4] 346711 0
Onset of DVT will be assessed by the review of medical record.
Timepoint [4] 346711 0
Post-injury/enrollment at baseline, 72-hours, 7-days, 14-days, 84-days, 180-days (primary endpoint) and 365-days.
Secondary outcome [5] 346712 0
Onset of pulmonary embolism will be assessed by the review of medical record.
Timepoint [5] 346712 0
Post-injury/enrollment at baseline, 72-hours, 7-days, 14-days, 84-days, 180-days (primary endpoint) and 365-days.

Eligibility
Key inclusion criteria
Participants will be included in the study if they have the same type and level of injury required for inclusion in RISCIS.
1. Age between 18 and 75 years.
2. Able to cooperate in the completion of standardized neurological examination by ISNCSCI standards.
3. ISNCSCI Impairment Scale Grade A, B or C based on first ISNCSCI evaluation on admission to hospital.
4. Neurological level of injury between C4 and C8 based on first ISNCSCI evaluation on admission to hospital.
5. Present to participating hospitals within 12 hours of injury.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant concomitant brain injury defined by Glasgow Coma Score <14 with a clinically significant abnormality on a head CT scan
2. Pre-existing neurological or mental health disorder which would preclude accurate evaluation and follow-up.
3. Previous spinal cord injury
4. Is a prisoner
5. Acquired immune deficiency syndrome (AIDS) or AIDS related complex.
6. Active malignancy or history of invasive malignancy in previous 5 years.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Comparative statistics for demographic data.
Multivariate analysis for neurological condition and complications.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2016
Date of last participant enrolment
Anticipated
Actual
18/02/2020
Date of last data collection
Anticipated
31/12/2022
Actual
24/02/2021
Sample size
Target
50
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10336 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 10337 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 22007 0
2031 - Randwick
Recruitment postcode(s) [2] 22008 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 298925 0
Other Collaborative groups
Name [1] 298925 0
AOSpine North America
Country [1] 298925 0
United States of America
Primary sponsor type
Individual
Name
Ralph Stanford
Address
Department of Orthopaedic Surgery, Prince of Wales Hospital, Barker Street, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 298139 0
None
Name [1] 298139 0
Address [1] 298139 0
Country [1] 298139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299863 0
Human Research Ethics Committee of South Eastern Sydney Local Health District
Ethics committee address [1] 299863 0
Room G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 299863 0
Australia
Date submitted for ethics approval [1] 299863 0
20/05/2014
Approval date [1] 299863 0
05/01/2016
Ethics approval number [1] 299863 0
LNR/14/POWH/284

Summary
Brief summary
This study is proposed to run alongside the approved Riluzole in Spinal Cord Injury Study (RISCIS) at Prince of Wales and Royal North Shore Hospitals. RISCIS is a randomized, prospective trial in acute cervical spinal cord injury. The outcome data that will be collected for this study will be good quality and detailed. Running RISCIS represents a unique opportunity to also collect ancillary observational data on possible predictors of general outcomes in acute spinal cord injury as well as the type and frequency of complications. This data will allow the investigators to generate reliable and accurate information on quality of care of acute spinal cord injury at both participating hospitals. This can be compared with international bench-marks and also allow comparison between the Spinal Units at the two hospitals. As a result, it is hoped that care can be optimized at each site in light of the new information and also that standardization of care across both Spinal Units can be established according to best practice guidelines. This study will be purely observational and will not require additional investigations or clinical assessments than used in standard clinical care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81802 0
Dr Ralph Stanford
Address 81802 0
Department of Orthopaedic Surgery
Level 2, South Wing Edmund Blacket Building
Prince of Wales Hospital
Barker Street, Randwick NSW 2031
Country 81802 0
Australia
Phone 81802 0
+61 2 9382 2490
Fax 81802 0
+61 2 9382 2890
Email 81802 0
ralph.stanford@health.nsw.gov.au
Contact person for public queries
Name 81803 0
Mr Trent Li
Address 81803 0
Department of Orthopaedic Surgery
Level 2, South Wing Edmund Blacket Building
Prince of Wales Hospital
Barker Street, Randwick NSW 2031
Country 81803 0
Australia
Phone 81803 0
+61 2 9382 2490
Fax 81803 0
+61 2 9382 2890
Email 81803 0
trent.li@health.nsw.gov.au
Contact person for scientific queries
Name 81804 0
Dr Ralph Stanford
Address 81804 0
Department of Orthopaedic Surgery
Level 2, South Wing Edmund Blacket Building
Prince of Wales Hospital
Barker Street, Randwick NSW 2031
Country 81804 0
Australia
Phone 81804 0
+61 2 9382 2490
Fax 81804 0
+61 2 9382 2890
Email 81804 0
ralph.stanford@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data collected from individual participant.
When will data be available (start and end dates)?
IPD will be available after the estimated date of study completion on 31-Dec-2022 and onwards.
Available to whom?
Available to general public and all research stakeholders.
Available for what types of analyses?
Meta-analysis method might be used, but it will be confirmed and finalised by PI.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, de-identified data can be retrieved from the OpenClinica database of the main RISCIS trial.


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.