The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury

November 12, 2020 updated by: University of Aarhus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • Traumatic spinal cord injury (Bony level C1-L1)
  • ISNCSCI score A-C upon inclusion.
  • Age >18-70 years.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Injured participants
Other: Blood samples

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.

Other: Cerebrospinal fluid sample

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.

Other: Clinical examination
Clinical examinations will be performed at <72 hours, 7 days and 365 days post-injury.
Healthy participants
Other: Blood samples

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.

Other: Cerebrospinal fluid sample

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time Frame: <72 hours, 7 days and 365 days post-injury.
<72 hours, 7 days and 365 days post-injury.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Walking Index for Spinal Cord Injury II (WISCI II)
Time Frame: 365 days post-injury
365 days post-injury
The Spinal Cord Independence Measure III (SCIM III)
Time Frame: 365 days post-injury
365 days post-injury
Visual Analogue Pain Score (VAS)
Time Frame: 365 days post-injury
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.
365 days post-injury
International Spinal Cord Injury Dataset for core
Time Frame: 365 days post-injury
365 days post-injury
International Spinal Cord Injury Dataset for pain
Time Frame: 365 days post-injury
365 days post-injury
International Spinal Cord Injury Dataset for bladder
Time Frame: 365 days post-injury
365 days post-injury
International Spinal Cord Injury Dataset for bowel
Time Frame: 365 days post-injury
365 days post-injury
International Spinal Cord Injury Dataset for sexual function
Time Frame: 365 days post-injury
365 days post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital
Spinal Cord Injury Centre of Western Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 490-13-3632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injury, Acute

Clinical Trials on Blood samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings