S100B in Intensive Care Patients With and Without Traumatic Brain Injury

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.

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Key information

Conditions

Tumor Accidental Injuries Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Critical Illness Disease Attributes Neoplasms Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery--Complications Trauma Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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:

ICU TBI, patients treated on the ICU with brain injury
ICU tumor, patients treated on the ICU because of an intracranial tumor
ICU surgery, patients treated on the ICU following surgery without brain injury
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood, cerebrospinal fluid and urine samples

Diagnostic Test

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.

Primary outcomes

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
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)

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2018
Study completion: 2019
First posted: Aug 6, 2020
Registry last updated: Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed