Detection of Immune Changes as a Result of Surgical Trauma in Human Subject
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mass cytometry of immune signaling events
研究概览
简要总结
Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study to characterize the cellular and molecular mechanisms immune response to surgical trauma. Additionally, detailed information about patients' recovery profile will be recorded over a period of 6 weeks, with the eventual goal of linking immune responses to recovery profiles.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planning to undergo hip surgery
- •Fluent in English
- •Willing and able to sign informed consent and HIPAA authorization
排除标准
- •Any systemic disease that might compromise the immune system
- •Diagnosis of cancer within the last 5 years
- •Psychiatric, immunological, and neurological conditions that would interfere with the collection and interpretation of study data
- •Pregnancy
- •Any other conditions that, in the opinion of the investigators, may compromise a participant's safety or the integrity of the study
结局指标
主要结局
Mass cytometry of immune signaling events
时间窗: Blood samples for mass cytometry will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.
The primary molecular outcome is the fold change in phosphorylation of signaling proteins.
次要结局
- Surgical Recovery Scale (SRS)(Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.)
- Plasma cytokines(Blood samples will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.)
研究者
Martin Angst
Professor of Anesthesia
Stanford University