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Traumatic Spinal Cord InjuryASCISNCT03109782

The Austrian Spinal Cord Injury Study

An observational study of Traumatic Spinal Cord Injury, run by Paracelsus Medical University at 18 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
Traumatic Spinal Cord Injury
How many people
1,000 participants
Where
18 sitesAustria
Study dates
Dec 2012to Dec 2023
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Primary Care Centers

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country.

Herbert Resch, Prof. M.D. contact

+43 662 2420-80101

herbert.resch@pmu.ac.at

Wolfgang Schaden, M.D. contact

+43 5 93 93-20170

wolfgang.schaden@auva.at

18 sites in 1 country

Austria18 sites, 18 recruiting

  • Hospital Amstetten, Department of Traumatology

    Amstetten

    Andreas Pachucki, M.D, Andreas.pachucki@amstetten.lknoe.at

    Recruiting

  • Ordensklinikum Barmherzige Brüder Eisenstadt, Department of Orthopaedic Surgery

    Eisenstadt

    Harald Boszotta, Prof. M.D., Harald.boszotta@bbeisen.at

    David Böckmann, David.Boeckmann@bbeisen.at

    Recruiting

  • Academic Hospital Feldkirch, Department for Trauma Surgery and Sports Traumatology

    Feldkirch

    Alexander Gohm, M.D., alexander.gohm@lkhf.at

    Michael Osti, Doz. M.D., michael.osti@lkhf.at

    Recruiting

  • Trauma Center Graz

    Graz

    Michael Plecko, M.D., Michael.plecko@auva.at;

    Günter Kohrgruber, M.D., guenter.kohrgruber@auva.at

    Recruiting

  • University Clinic Graz, Department of Orthopaedics and Traumatology, Medical University Graz

    Graz

    Fraz Josef Seibert, Prof. M.D., Franz-Josef.Seibert@klinikum-graz.at

    Ellen Tackner, M.D., Ellen.tackner@medunigraz.at

    Recruiting

  • Hospital Horn, Department of Traumatology

    Horn

    Thomas Neubauer, M.D., Thomas.Neubauer@horn.lknoe.at

    Recruiting

  • Hospital Klagenfurt, Department of Trauma Surgery and Sports Traumatology

    Klagenfurt

    Ernst Müller, Prof. M.D., ernst.mueller@kabeg.at

    Arnold Gstrein, M.D., arnold.gstrein@kabeg.at

    Recruiting

  • Trauma Center Klagenfurt

    Klagenfurt

    Vinzenz Smekal, Doz. M.D., vinzenz.smekal@auva.at

    Recruiting

  • Trauma Center Linz, Teaching Hospital of the Paracelsus Medical University Linz

    Linz

    Klaus Katzensteiner, M.D., Klaus.Katzensteiner@auva.at

    Georg Mattiassich, M.D., georg.mattiassich@auva.at

    Recruiting

  • University Clinic Linz, Department of Neurosurgery, Kepler University Linz

    Linz

    Andreas Gruber, Prof. M.D., andreas.gruber@gespag.at

    Recruiting

  • University Clinic Linz, Department of Orthopaedics and Traumatology, Kepler University Linz

    Linz

    Oskar Kwasny, Prof. M.D., oskar.kwasny@kepleruniklinikum.at

    Recruiting

  • Trauma Center Salzburg, Teaching Hospital of the Paracelsus Medical University Salzburg

    Salzburg

    Josef Obrist, M.D., josef.obrist@auva.at

    Recruiting

  • University Clinic Salzburg, Department of Orthopaedics and Traumatology, Paracelsus Medical University

    Salzburg

    Thomas Freude, Prof. M.D., 00435 7255-50001, t.freude@salk.at

    Recruiting

  • University Clinic St. Pölten, Department of Orthopaedics and Traumatology

    Sankt Pölten

    Hermann Schnell, M.D., hermann.schnell@stpoelten.lknoe.at

    Alexander Wels, M.D., Alexander.wels@stpoelten.lknoe.at

    Recruiting

  • Lorenz Böhler Trauma Center Vienna

    Vienna

    Thomas Hausner, Prof. M.D., thomas.hausner@auva.at

    Recruiting

  • SMZ Ost Donauspital, Department of Traumatology

    Vienna

    Mehdi Mousavi, Prof. M.D., mehdi.mousavi@meduniwien.ac.at

    Recruiting

  • University Clinic Vienna, Department of Trauma Surgery, Medical University of Vienna

    Vienna

    Gholam Pajenda, Prof. M.D., gholam.pajenda@meduniwien.ac.at

    Recruiting

  • Hospital Wiener Neustadt, Department of Traumaotlogy

    Wiener Neustadt

    Franz Ortner, M.D., franz.ortner@wienerneustadt.lknoe.at

    Recruiting

Other trials in Austria

About this study

Official title: The Austrian Spinal Cord Injury Study (ASCIS)

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).

Keywords
Spinal Cord Injury, Spine Surgery, Patient Registry, Trauma
Medical subject headings
Spinal Cord Injuries, Wounds and Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in American Spinal Injury Association Impairment Scale (AIS)

    Measured: 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)

  1. Change in American Spinal Injury Association Motor Score (ASIAMS)

    Measured: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

  2. Change in American Spinal Injury Association Sensory Score (ASIASS)

    Measured: 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. Change in Spinal Cord Independency Measure (SCIM)

    Measured: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

  4. Change in Walking Index for Spinal Cord Injury (WISCI II)

    Measured: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

  5. Change in Timed Up and Go Test (TuG)

    Measured: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

  6. Change in 6 Minute Walking Test (6MWT)

    Measured: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

  7. Change in 10 Meter Timed Walk (10MTW)

    Measured: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

  8. Change in quality of life using the Short Form 36 (SF-36) questionnaire

    Measured: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study startDec 2012
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03109782
Sponsor's protocol ID
ascis1411
Acronym
ASCIS
Status last verified
Aug 2018
First submitted
31 Mar 2017
Last updated
28 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Spinal Cord Injury, run by Paracelsus Medical University at 18 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Herbert Resch, Prof. M.D. (+43 662 2420-80101, herbert.resch@pmu.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in American Spinal Injury Association Impairment Scale (AIS) (time frame: Between day of trauma (0 day), 1-3 days, 14-40 days, 3 months, 6 months, 1 year and 2-3 years after injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03109782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.

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