Clinical trial NCT03109782: The Austrian Spinal Cord Injury Study
Official title: The Austrian Spinal Cord Injury Study (ASCIS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Spinal Cord Injury
Keywords: Spinal Cord Injury
Spine Surgery
Patient Registry
Trauma
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Centers

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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in American Spinal Injury Association Impairment Scale (AIS)
timeFrame: 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:
measure: Change in American Spinal Injury Association Motor Score (ASIAMS)
timeFrame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
measure: Change in American Spinal Injury Association Sensory Score (ASIASS)
timeFrame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
measure: Change in Spinal Cord Independency Measure (SCIM)
timeFrame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
measure: Change in Walking Index for Spinal Cord Injury (WISCI II)
timeFrame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
measure: Change in Timed Up and Go Test (TuG)
timeFrame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
measure: Change in 6 Minute Walking Test (6MWT)
timeFrame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
measure: Change in 10 Meter Timed Walk (10MTW)
timeFrame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
measure: Change in quality of life using the Short Form 36 (SF-36) questionnaire
timeFrame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Hospital Amstetten, Department of Traumatology
city: Eisenstadt
country: Austria
facility: Ordensklinikum Barmherzige Brüder Eisenstadt, Department of Orthopaedic Surgery
city: Feldkirch
country: Austria
facility: Academic Hospital Feldkirch, Department for Trauma Surgery and Sports Traumatology
city: Graz
country: Austria
facility: Trauma Center Graz
city: Graz
country: Austria
facility: University Clinic Graz, Department of Orthopaedics and Traumatology, Medical University Graz
city: Horn
country: Austria
facility: Hospital Horn, Department of Traumatology
city: Klagenfurt
country: Austria
facility: Hospital Klagenfurt, Department of Trauma Surgery and Sports Traumatology
city: Klagenfurt
country: Austria
facility: Trauma Center Klagenfurt
city: Linz
country: Austria
facility: Trauma Center Linz, Teaching Hospital of the Paracelsus Medical University Linz
city: Linz
country: Austria
facility: University Clinic Linz, Department of Neurosurgery, Kepler University Linz
city: Linz
country: Austria
facility: University Clinic Linz, Department of Orthopaedics and Traumatology, Kepler University Linz
city: Salzburg
country: Austria
facility: Trauma Center Salzburg, Teaching Hospital of the Paracelsus Medical University Salzburg
city: Salzburg
country: Austria
facility: University Clinic Salzburg, Department of Orthopaedics and Traumatology, Paracelsus Medical University
city: St. Pölten
country: Austria
facility: University Clinic St. Pölten, Department of Orthopaedics and Traumatology
city: Vienna
country: Austria
facility: Lorenz Böhler Trauma Center Vienna
city: Vienna
country: Austria
facility: SMZ Ost Donauspital, Department of Traumatology
city: Vienna
country: Austria
facility: University Clinic Vienna, Department of Trauma Surgery, Medical University of Vienna
city: Wiener Neustadt
country: Austria
facility: Hospital Wiener Neustadt, Department of Traumaotlogy
Study officials:
affiliation: Paracelsus Medical University
name: Herbert Resch, Prof. M.D.
role: STUDY_CHAIR
affiliation: University Clinic Salzburg, Department of Traumatology and Orthopaedics
name: Thomas Freude, Prof. M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Austrian Social Insurance for Occupational Risks (AUVA)
name: Wolfgang Schaden, M.D. Dir.
role: STUDY_DIRECTOR
References: