None listed
Conditions
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.
Interventions
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 ev
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.
Sponsors
Ralph Stanford
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed