S100B in Intensive Care Patients With and Without Traumatic Brain Injury

Completed

• Conditions: Critical Illness; Surgery--Complications; Tumor; Trauma Injury; Brain Injuries
• Interventions: Diagnostic Test: Blood, cerebrospinal fluid and urine samples

• Registration Number: NCT04501315
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

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.

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 Timeline

• Study Start: 2007-07-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30
• Study First Submitted: 2020-07-29
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-05
• Last Update Submitted: 2020-08-05
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU TBI	Blood, cerebrospinal fluid and urine samples	Patients treated on the ICU with brain injury
ICU tumor	Blood, cerebrospinal fluid and urine samples	Patients treated on the ICU because of intracranial tumor
ICU surgery	Blood, cerebrospinal fluid and urine samples	Patients treated on the ICU following surgery without brain injury
ICU control	Blood, cerebrospinal fluid and urine samples	Patients treated on the ICU without TBI, tumor or surgery

Primary Outcome Measures

Name	Time	Method
Karnofsky Performance Status Score	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)
Glascow Outcome Score (GOS)	up to one year post admission	The Glascow Outcome Scale classifies patients by objective degree of recovery, Minimum 1: death - Maximum 5: good recovery