S100B in Intensive Care Patients With and Without Traumatic Brain Injury: Implications for Neuromarker Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 主要终点
- Karnofsky Performance Status Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •age under 18
- •pregnancy
结局指标
主要结局
Karnofsky Performance Status Score
时间窗: 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)
时间窗: up to one year post admission
The Glascow Outcome Scale classifies patients by objective degree of recovery, Minimum 1: death - Maximum 5: good recovery
次要结局
未报告次要终点
研究者
Andrea Kleindienst, MD, PhD
Associate Professor
University of Erlangen-Nürnberg Medical School