Spinal Cord Injury, AcuteNCT03505463
The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury
An observational study of Spinal Cord Injury, Acute, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study is a prospective cohort study designed to assess the diagnostic and prognostic potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to examine the neuroinflammatory response to acute TSCI. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Acute
- What is being tested?
- Blood samples, Cerebrospinal fluid sample and Clinical examination
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 1 Dec 2020
- 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: The study population consist of 10 acute traumatic spinal cord injured participants admitted to the Department of Neurosurgery at Aarhus University Hospital and 20 healthy participants investigated at the Department of Neurology at Aarhus University Hospital.
Who may be able to join
- Traumatic spinal cord injury (Bony level C1-L1)
- ISNCSCI score A-C upon inclusion.
- Age >18-70 years.
Who cannot join
- Prior major spine surgery in the traumatised location.
- Major co-morbidities or co-injuries.
- Penetrating spinal cord injury.
- >72 hours from injury to sample collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury: A Pilot Study
The study is a prospective cohort study designed to assess the diagnostic and prognostic potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to examine the neuroinflammatory response to acute TSCI.
Read the detailed description
TSCI is an incurable condition with devastating consequences. The physical, psychosocial and financial implications in addition to a variable recovery and an uncertain prognosis have a profound impact on quality of life.The pathophysiology of TSCI is dual consisting of a primary injury and a secondary injury. The immediate trauma to the spinal cord and nerve roots causes the primary injury, while a prolonged cascade of events causes the secondary injury. The neuroinflammatory response is considered to be an important event. Current clinical measures to evaluate acute TSCI consist of clinical examination and routine imaging modalities. These measurements are inaccurate to assess injury severity, prognosis, and therapeutic efficacy, especially in the early acute phase. Biomarker measurement may provide a more accurate measure.
This study aim to assess the diagnostic and prognostic potential of biomarker measurement in acute TSCI, and to examine the neuroinflammatory response to acute TSCI. To achieve this, immune cells, cytokines, autoantibodies and structural proteins will be analysed in blood and cerebrospinal fluid by Flow Cytometry and assay techniques. These analyses will be correlated to clinical outcome assessed according to international standards.
Hopefully, this will contribute with new knowledge of the neuroinflammatory response and biomarkers in acute TSCI, and provide the needed knowledge for conducting futures trials in novel therapeutic interventions.
- Conditions
- Spinal Cord Injury, Acute
- Being tested
- Blood samples, Cerebrospinal fluid sample, Clinical examination
- Keywords
- Spinal cord injury, Biomarkers, Inflammation, Trauma
- Medical subject headings
- Spinal Cord Injuries, Inflammation, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Three blood samples will be collected from the injured participants. The assessment points are <72 hours, 7 days and 365 days post-injury.
One blood sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Cerebrospinal fluid sampleOther
Three cerebrospinal fluid samples will be collected from the injured participants. The assessment points are <72 hours, 7 days and 365 days post-injury.
The collected samples will be analysed by Flow Cytometry and assay techniques. One cerebrospinal fluid sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Clinical examinationOther
Clinical examinations will be performed at <72 hours, 7 days and 365 days post-injury.
| Study group | Role | What they receive |
|---|---|---|
| Injured participants | Not described Receives: Other: Blood samples; Other: Cerebrospinal fluid sample; Other: Clinical examination | |
| Healthy participants | Not described Receives: Other: Blood samples; Other: Cerebrospinal fluid sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Measured: <72 hours, 7 days and 365 days post-injury.
Secondary outcomes (8)
Walking Index for Spinal Cord Injury II (WISCI II)
Measured: 365 days post-injury
The Spinal Cord Independence Measure III (SCIM III)
Measured: 365 days post-injury
Visual Analogue Pain Score (VAS)
VAS will be used to assess pain intensity. VAS is a scale ranging from 0 to 10 where "No pain" gives a score of 0 and "worst imaginable pain" gives a score of 10.
Measured: 365 days post-injury
International Spinal Cord Injury Dataset for core
Measured: 365 days post-injury
International Spinal Cord Injury Dataset for pain
Measured: 365 days post-injury
International Spinal Cord Injury Dataset for bladder
Measured: 365 days post-injury
International Spinal Cord Injury Dataset for bowel
Measured: 365 days post-injury
International Spinal Cord Injury Dataset for sexual function
Measured: 365 days post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 May 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury, AcuteStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Spinal Cord Injury Centre of Western Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505463
- Sponsor's protocol ID
- 490-13-3632
- Status last verified
- Nov 2020
- First submitted
- 11 Apr 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wichmann TO, Kasch H, Dyrskog S, Hoy K, Moller BK, Krog J, Hoffmann HJ, Hviid CVB, Rasmussen MM. Glial fibrillary acidic protein is a robust biomarker in cerebrospinal fluid and peripheral blood after traumatic spinal cord injury: a prospective pilot study. Acta Neurochir (Wien). 2023 Jun;165(6):1417-1425. doi: 10.1007/s00701-023-05520-x. Epub 2023 Feb 15.
PubMed 36790588
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT03505463
- Acronym / sponsor ID
- 490-13-3632
- Conditions
- Spinal Cord Injury, Acute
- Keywords
- Spinal cord injury, Biomarkers, Inflammation, Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Spinal Cord Injury Centre of Western Denmark
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a prospective cohort study designed to assess the diagnostic and prognostic potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to examine the neuroinflammatory response to acute TSCI.
Detailed description
TSCI is an incurable condition with devastating consequences. The physical, psychosocial and financial implications in addition to a variable recovery and an uncertain prognosis have a profound impact on quality of life.The pathophysiology of TSCI is dual consisting of a primary injury and a secondary injury. The immediate trauma to the spinal cord and nerve roots causes the primary injury, while a prolonged cascade of events causes the secondary injury. The neuroinflammatory response is considered to be an important event. Current clinical measures to evaluate acute TSCI consist of clinical examination and routine imaging modalities. These measurements are inaccurate to assess injury severity, prognosis, and therapeutic efficacy, especially in the early acute phase. Biomarker measurement may provide a more accurate measure.
This study aim to assess the diagnostic and prognostic potential of biomarker measurement in acute TSCI, and to examine the neuroinflammatory response to acute TSCI. To achieve this, immune cells, cytokines, autoantibodies and structural proteins will be analysed in blood and cerebrospinal fluid by Flow Cytometry and assay techniques. These analyses will be correlated to clinical outcome assessed according to international standards.
Hopefully, this will contribute with new knowledge of the neuroinflammatory response and biomarkers in acute TSCI, and provide the needed knowledge for conducting futures trials in novel therapeutic interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injured participants | – | Other: Blood samples, Other: Cerebrospinal fluid sample, Other: Clinical examination |
| Healthy participants | – | Other: Blood samples, Other: Cerebrospinal fluid sample |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consist of 10 acute traumatic spinal cord injured participants admitted to the Department of Neurosurgery at Aarhus University Hospital and 20 healthy participants investigated at the Department of Neurology at Aarhus University Hospital.
Key inclusion criteria (3 listed)
- Traumatic spinal cord injury (Bony level C1-L1)
- ISNCSCI score A-C upon inclusion.
- Age >18-70 years.
Key exclusion criteria (4 listed)
- Prior major spine surgery in the traumatised location.
- Major co-morbidities or co-injuries.
- Penetrating spinal cord injury.
- >72 hours from injury to sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesThree blood samples will be collected from the injured participants. The assessment points are <72 hours, 7 days and 365 days post-injury. One blood sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital. Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques. | Other | Healthy participants, Injured participants |
| Cerebrospinal fluid sampleThree cerebrospinal fluid samples will be collected from the injured participants. The assessment points are <72 hours, 7 days and 365 days post-injury. The collected samples will be analysed by Flow Cytometry and assay techniques. One cerebrospinal fluid sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital. Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques. | Other | Healthy participants, Injured participants |
| Clinical examinationClinical examinations will be performed at <72 hours, 7 days and 365 days post-injury. | Other | Injured participants |
Primary outcome
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: <72 hours, 7 days and 365 days post-injury.
8 secondary outcomes
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: 365 days post-injury
The Spinal Cord Independence Measure III (SCIM III)
Time frame: 365 days post-injury
Visual Analogue Pain Score (VAS)
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for core
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for pain
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for bladder
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for bowel
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for sexual function
Time frame: 365 days post-injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 36790588Wichmann TO, Kasch H, Dyrskog S, Hoy K, Moller BK, Krog J, Hoffmann HJ, Hviid CVB, Rasmussen MM. Glial fibrillary acidic protein is a robust biomarker in cerebrospinal fluid and peripheral blood after traumatic spinal cord injury: a prospective pilot study. Acta Neurochir (Wien). 2023 Jun;165(6):1417-1425. doi: 10.1007/s00701-023-05520-x. Epub 2023 Feb 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, Acute, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 4 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (time frame: <72 hours, 7 days and 365 days post-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 NCT03505463, which also lists 1 linked publication.
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 13 Nov 2020.