跳至主要内容
临床试验/NCT00178659
NCT00178659已完成不适用

Proteomics of Brain Trauma-associated Elevated Intracranial Pressure (ICP)

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2004年8月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
2
主要终点
Elevated intracranial pressure

研究概览

简要总结

The specific aim of this research is to determine if the blood from brain-injured patients contains reproducible protein markers that appear prior to elevations in intracranial pressure (ICP).

详细描述

One of the major causes of death following brain trauma is increased intracranial pressure (ICP). Currently, there are no effective ways to predict if the ICP of a patient will reach uncontrollable levels. Various cytokines (balance between pro-and anti-inflammatory) and other factors are thought to underlie increases in ICP. The specific aim of this research is to determine if the blood from brain-injured patients contains reproducible protein markers that appear prior to elevations in ICP. We propose to employ mass spectrometry, antibody array and ELISA to profile proteins in the serum of patients suffering from traumatic brain injury. These protein profiles will be compiled by a pattern recognition program that has the capacity to learn and make predictions based on the spectra and associated patient information. Each time a sample is analyzed, it is added to the database allowing the program to make increasingly accurate predictions. Protein profiles of patients with known ICP values will be analyzed. Our hypothesis is that alterations in serum protein composition will precede changes in intracranial pressure giving rise to predictable patterns that can be detected using large-scale proteomic analysis. After approximately 90 non-brain trauma and 90 brain-trauma patients are analyzed, if markers are found, the predictability of elevated ICP will be tested. If successful, this may aid the neurosurgeon in determining future courses of treatment.

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
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 14-65 years old
  • Non-penetrating brain injury
  • ICP monitor or
  • Healthy volunteer or
  • The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following:
  • Fracture confirmed radiographically
  • No head trauma
  • No other known inflammatory process or infection
  • No history of neurological or psychiatric disorders or alcohol or drug dependency.
  • or The mild TBI patients will be defined as those experiencing,
  • Non-penetrating head trauma manifesting one or more of the following:
  • Loss of consciousness
  • Post-traumatic amnesia
  • Altered mental status
  • Focal neurologic deficits, seizure
  • No abnormalities on CT other than contusion
  • No operative Lesions
  • Length of hospital stay < 48 hrs
  • No other known inflammatory process or infection
  • No history of neurological or psychiatric disorders or alcohol or drug dependency

排除标准

  • Inability to obtain informed consent

研究组 & 干预措施

1 healthy volunteers

Healthy volunteers to act as controls - Recruitment is complete for this cohort

干预措施: Blood/saliva samples for protein/molecular analysis (Other)

2 head trauma

Head trauma patients meeting enrollment criteria - Recruitment is complete for this cohort

干预措施: Blood/saliva samples for protein/molecular analysis (Other)

3 orthopedic injury

The orthopedic injury cohort will include patients admitted to the ED able to provide informed consent with the following:

  1. Fracture confirmed radiographically
  2. No head trauma
  3. No other known inflammatory process or infection
  4. No history of neurological or psychiatric disorders or alcohol or drug dependency Recruitment is complete.

干预措施: Blood/saliva samples for protein/molecular analysis (Other)

4 Mild TBI

The mild TBI patients will be defined as those admitted to the ED experiencing, - Recruitment is complete for this cohort

  1. Non-penetrating head trauma manifesting one or more of the following:
  • Loss of consciousness
  • Post-traumatic amnesia
  • Altered mental status
  • Focal neurologic deficits, seizure
  1. GCS> 12
  2. No abnormalities on CT other than contusion
  3. No operative Lesions
  4. Length of hospital stay < 48 hrs
  5. No other known inflammatory process or infection
  6. No history of neurological or psychiatric disorders or alcohol or drug dependency Recruitment is complete.

干预措施: Blood/saliva samples for protein/molecular analysis (Other)

结局指标

主要结局

Elevated intracranial pressure

时间窗: within the first 10 days post injury

Intracranial pressure \>20mmHg

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

Georgene Hergenroeder

Associate Professor, Neurosurgery

The University of Texas Health Science Center, Houston

研究点 (2)

Loading locations...

相似试验

Proteomics of Brain Trauma-associated Elevated... | 临床试验