NCT03505463

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

April 11, 2018

Last Update Submit

November 12, 2020

Conditions

Spinal Cord Injury, Acute

Keywords

Spinal cord injuryBiomarkersInflammationTrauma

Outcome Measures

Primary Outcomes (1)

  • Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

    <72 hours, 7 days and 365 days post-injury.

Secondary Outcomes (8)

  • Walking Index for Spinal Cord Injury II (WISCI II)

    365 days post-injury

  • The Spinal Cord Independence Measure III (SCIM III)

    365 days post-injury

  • Visual Analogue Pain Score (VAS)

    365 days post-injury

  • International Spinal Cord Injury Dataset for core

    365 days post-injury

  • International Spinal Cord Injury Dataset for pain

    365 days post-injury

  • +3 more secondary outcomes

Study Arms (2)

Injured participants

Other: Blood samplesOther: Cerebrospinal fluid sampleOther: Clinical examination

Healthy participants

Other: Blood samplesOther: Cerebrospinal fluid sample

Interventions

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.

Healthy participantsInjured participants
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.

Healthy participantsInjured participants
Clinical examinationOTHER

Clinical examinations will be performed at \<72 hours, 7 days and 365 days post-injury.

Injured participants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Traumatic spinal cord injury (Bony level C1-L1)
  • Age \>18-70 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 36790588DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesInflammationWounds and Injuries

Interventions

Blood Specimen CollectionRestraint, Physical

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesBehavior ControlTherapeuticsImmobilization

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 23, 2018

Study Start

May 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)