The Austrian Spinal Cord Injury Study
ASCIS
1 other identifier
observational
1,000
1 country
18
Brief Summary
Traumatic spinal cord injury (tSCI) is a debilitating disease that leads to neurological deficits and often has long-term effects including severe lifelong disability. Given the devastating personal and economic consequences of SCI, it is critical to collect high-quality, prospective data. SCI has not been systemically assessed in Austria, and data regarding the etiology, incidence and prevalence are missing or significantly limited. More importantly to the individuals suffering from SCI, health care for SCI patients in Austria is not concentrated in specialized SCI centers but fragmented, which might result in a less effective recovery and rehabilitation of patients. Accordingly, the Paracelsus Medical University Salzburg (PMU) and the Austrian Social Insurance for Occupational Risks (AUVA) initiated the Austrian Spinal Cord Injury Study (ASCIS) at the beginning of 2012. ASCIS is defined as an organized network that uses observational methods to collect uniform longitudinal clinical data that can provide insight into current patient care parameters and evaluates the outcome of SCI patients. ASCIS was initiated with the aim to develop a registry for patients with tSCI in Austria as a base for addressing research questions, improving patient outcomes and establishing a platform for future clinical trials. Furthermore, a major goal of ASCIS is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and bring new standardized assessment tools to the clinical setting. Due to the involvement of acute trauma hospitals and rehabilitation centers, ASCIS is uniquely positioned to capture detailed hospital-related information on the (very)-acute, rehabilitation and chronic phases of tSCI patients. Additionally, ASCIS is cooperation partner of the European Multi-Center Study about Spinal Cord Injury (EMSCI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 28, 2018
August 1, 2018
11 years
March 31, 2017
August 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in American Spinal Injury Association Impairment Scale (AIS)
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Secondary Outcomes (8)
Change in American Spinal Injury Association Motor Score (ASIAMS)
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in American Spinal Injury Association Sensory Score (ASIASS)
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in Spinal Cord Independency Measure (SCIM)
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in Walking Index for Spinal Cord Injury (WISCI II)
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Change in Timed Up and Go Test (TuG)
Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
- +3 more secondary outcomes
Eligibility Criteria
Primary Care Centers
You may qualify if:
- Patients suffering from paresis or plegia after trauma
- First ASCIS assessment possible within the first 3 days after incidence
- Patient capable and willing of giving written informed consent
- No cognitive impairment which would preclude an informed consent (including severe traumatic brain injury)
You may not qualify if:
- Nontraumatic paresis or plegia (e.g. disc-herniation, tumor, AV-malformation, myelitis)
- Previously known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
- Peripheral nerve lesion above the level of lesion (e.g. Plexus brachialis impairment)
- Previously known polyneuropathy
- Severe craniocerebral injury
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Hospital Amstetten, Department of Traumatology
Amstetten, Austria
Ordensklinikum Barmherzige Brüder Eisenstadt, Department of Orthopaedic Surgery
Eisenstadt, Austria
Academic Hospital Feldkirch, Department for Trauma Surgery and Sports Traumatology
Feldkirch, Austria
Trauma Center Graz
Graz, Austria
University Clinic Graz, Department of Orthopaedics and Traumatology, Medical University Graz
Graz, Austria
Hospital Horn, Department of Traumatology
Horn, Austria
Hospital Klagenfurt, Department of Trauma Surgery and Sports Traumatology
Klagenfurt, Austria
Trauma Center Klagenfurt
Klagenfurt, Austria
Trauma Center Linz, Teaching Hospital of the Paracelsus Medical University Linz
Linz, Austria
University Clinic Linz, Department of Neurosurgery, Kepler University Linz
Linz, Austria
University Clinic Linz, Department of Orthopaedics and Traumatology, Kepler University Linz
Linz, Austria
Trauma Center Salzburg, Teaching Hospital of the Paracelsus Medical University Salzburg
Salzburg, Austria
University Clinic Salzburg, Department of Orthopaedics and Traumatology, Paracelsus Medical University
Salzburg, Austria
University Clinic St. Pölten, Department of Orthopaedics and Traumatology
Sankt Pölten, Austria
Lorenz Böhler Trauma Center Vienna
Vienna, Austria
SMZ Ost Donauspital, Department of Traumatology
Vienna, Austria
University Clinic Vienna, Department of Trauma Surgery, Medical University of Vienna
Vienna, Austria
Hospital Wiener Neustadt, Department of Traumaotlogy
Wiener Neustadt, Austria
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Herbert Resch, Prof. M.D.
Paracelsus Medical University
- PRINCIPAL INVESTIGATOR
Thomas Freude, Prof. M.D.
University Clinic Salzburg, Department of Traumatology and Orthopaedics
- STUDY DIRECTOR
Wolfgang Schaden, M.D. Dir.
Austrian Social Insurance for Occupational Risks (AUVA)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Head of Traumatology
Study Record Dates
First Submitted
March 31, 2017
First Posted
April 12, 2017
Study Start
December 1, 2012
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
August 28, 2018
Record last verified: 2018-08