S100B in Intensive Care Patients With and Without Traumatic Brain Injury

August 5, 2020 updated by: Andrea Kleindienst, MD, PhD, University of Erlangen-Nürnberg Medical School

S100B in Intensive Care Patients With and Without Traumatic Brain Injury: Implications for Neuromarker Assessment

The neurotrophic protein S100B has been promoted as a neuromarker for decades, and to reflect the severity of brain injury. On the other hand, S100B is a tumor marker. The interpretation of its serum levels may be altered by a contribution from extracerebral sources and its renal elimination.

In the present study we investigate the relevance of S100B as a prognostic factor, as well as the correlation with different CT classifications in a large cohort of patients with and without brain injury. Furthermore, we examine whether S100B is elevated in brain tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg, undergoing surgery for sellar lesions were prospectively included. The study protocol was approved by the local Ethical Committee. Informed written consent was given by the participants or the next-of-kin in each case. Exclusion criteria comprised of those below 18 years of age, pregnancy and a drug intolerance.

Patients baseline information included age, gender, clinical presentation, and preexisting medical conditions. In four different cohorts of patients, S100B was measured:

  1. ICU TBI, patients treated on the ICU with brain injury
  2. ICU tumor, patients treated on the ICU because of an intracranial tumor
  3. ICU surgery, patients treated on the ICU following surgery without brain injury
  4. ICU control, patients treated on the ICU without TBI, tumor or surgery

The performed diagnostic tests included blood, cerebrospinal fluid and urine samples. In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.

Samples were immediately centrifuged for 10min at 1.300xG and 4°C and stored at a temperature of -80°C until the assays were performed. Analysis was performed with commercially available kits on automated immunoanalyzers (LIAISON® Sangtec®100 by chemiluminescence immunoassay, Diasorin). The sensitivity of the assay was 0.02ng/ml.

In all cohorts the clinical status was documented with Glasgow Coma Score (GCS), and the outcome was assessed applying the Glasgow Outcome Score (GOS) or the Karnofsky Status Scale. The radiological work-up included a computed tomography (CT) or a magnetic resonance imaging (MRI). In brain injured patients, the CT was classifiied by the Marshall and Rotterdam Score. Extracranial injuries or surgical procedures were documented

Statistical analysis was performed with SPSS, and p<0.05 was accepted as significant.

Study Type

Observational

Enrollment (Actual)

600

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of the Department of Neurosurgery, University of Erlangen-Nuremberg,

Description

Inclusion Criteria:

  • patients of the Department of Neurosurgery, University of Erlangen Nürnberg, patients with traumatic brain injury,
  • patients with intracranial tumor,
  • intensive care patients,
  • informed written consent was given by the Patient or the next of kin in each case.

Exclusion Criteria:

  • age under 18
  • pregnancy

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
Intervention / Treatment
ICU TBI
Patients treated on the ICU with brain injury
Diagnostic test: Blood, cerebrospinal fluid and urine samples
In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.
ICU tumor
Patients treated on the ICU because of intracranial tumor
Diagnostic test: Blood, cerebrospinal fluid and urine samples
In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.
ICU surgery
Patients treated on the ICU following surgery without brain injury
Diagnostic test: Blood, cerebrospinal fluid and urine samples
In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.
ICU control
Patients treated on the ICU without TBI, tumor or surgery
Diagnostic test: Blood, cerebrospinal fluid and urine samples
In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glascow Outcome Score (GOS)
Time Frame: up to one year post admission
The Glascow Outcome Scale classifies patients by objective degree of recovery, Minimum 1: death - Maximum 5: good recovery
up to one year post admission
Karnofsky Performance Status Score
Time Frame: up to one year post admission
Karnofsky Performance Status Scale describes patients functional status as a comprehensive 11 point scale correlatig to percentage values ranging from 100% ( no evidence of disease, no symptoms) to 0% ( death)
up to one year post admission

Collaborators and Investigators

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

Sponsor

University of Erlangen-Nürnberg Medical School

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)

July 1, 2007

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S100B ICU

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.

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