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临床试验/NCT01846546
NCT01846546已完成不适用

Dynamic Changes of Cerebrospinal Fluid Endostatin Concentrations in Patients With Severe Traumatic Brain Injury.

Shanghai 6th People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Enzyme-linked immunosorbent assay

研究概览

简要总结

Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the secondary brain injury following TBI. The aim of this study was to investigate early changes in the concentrations of CSF endostatin/collagen XVIII after TBI and evaluated the relations of endostatin/collagen XVIII to injury severity and clinical outcome. Endostatin/collagen XVIII concentrations were measured serially for 1 week after hospitalization by using the enzyme linked immunosorbent assay method in the cerebrospinal fluid of 30 patients with TBI and a Glasgow Coma Scale score of 8 or less on admission. Comparative analysis were used to determine if its serial changes correlate with the GCS score and prognosis. Receiver operating characteristic curve was used to appraise the value of CSF endostatin/collagen XVIII levels in predicting the prognosis of patients with severe head injury.

详细描述

Patients with severe TBI (Glasgow Coma Scale score of 8 or less) requiring continuous lumbar drainage of CSF were included in the study. Patients delivered within 4 h whose highest abbreviated injury score was 3 or less (other than head injury) were considered to be isolated TBI cases and were included. To avoid interfering factors, patients who suffered open or combined injuries, had existing prior neurological disease were excluded. Those who died within the first week of hospitalization and/or whose serial cerebrospinal fluid samples could not be obtained were also excluded as having incomplete data. Accordingly, 30 patients were analyzed in this study. Demographic data, including age, gender, mechanism of trauma and GCS score at admission were documented when the patients arrived at the emergency room. The control group comprised 20 patients whose cerebrospinal fluid was examined via lumbar puncture for investigation of suspected neurological disease. All patients had normal neurological examination, negative imaging studies, and none had evidence of trauma or preexisting neurological disease, including tumors, vascular anomalies, or abnormalities of cerebrospinal fluid. The study had approval from the hospital ethics committee and informed consent for participating in the study was obtained from an appropriate member of each patient's family before performance of lumbar drainage.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 82 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with severe TBI (GCS score of 8 or less) requiring continuous lumbar drainage of CSF. Patients delivered within 4 h whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) were considered to be isolated TBI cases and were included.

排除标准

  • Patients who suffered open or combined injuries, had existing prior neurological disease were excluded. Those who died within the first week of hospitalization and/or whose serial CSF samples could not be obtained were also excluded as having incomplete data.

结局指标

主要结局

Enzyme-linked immunosorbent assay

时间窗: 6 months

This assay employs the quantitative sandwich enzyme immunoassay technique. In brief, a monoclonal antibody specific for endostatin/collagen XVIII had been pre-coated onto a microplate.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Chen

Doctor

Shanghai 6th People's Hospital

研究点 (1)

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