Analysis of the Danger Response After Polytrauma Based on the National Polytrauma-serum-bank of the Trauma Research Network (NTF) of the German Society for Orthopaedics and Trauma (DGOU)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Interleukin-6 (IL-6) plasma concentration
研究概览
简要总结
The NTF_PT_2014 multicenter study aims to collect, store, and analyse plasma and serum from polytrauma-patients (injury severity score ≥25) and corresponding clinical data to address 1) how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers, 2) how the specific injury pattern affects the posttraumatic response and regenerative potential on an organ-, cell, and molecular level, and 3) how could a specific organ- and immune-monitoring predict the clinical outcome.
详细描述
Polytrauma is worldwide a major socio-economic problem. Especially the polytrauma-induced complications, such as systemic inflammatory response, sepsis, organ dysfunction remain associated with a high morbidity and mortality rate. The underlying posttraumatic pathophysiology remains poorly understood, especially since the polytrauma patients present a highly variable patient cohort with complex injury patterns, comorbidities and different therapeutic strategies.
Therefore, the present "NTF_PT_2014" multicenter study of the Trauma Research Network (NTF) of the German Society for Orthopaedics and Trauma (DGOU) with its established national Polytrauma-serum-bank aims to collect, store, and analyse plasma and serum from polytrauma-patients and corresponding clinical data to address:
- how trauma modulates the release of danger molecules, inflammatory mediators, coagulation factors and novel biomarkers?
- how the specific injury pattern affects the posttraumatic response and regenerative potential on a organ-, cell, and molecular level?
- how could a specific organ- and immune-monitoring predict the clinical outcome?
Blood will be drawn from anticipated 1000 patients with an injury severity score ≥ 25 at the time of hospital admission (in the emergency room), 8 h, 24h, 48, 120 h, and 240 h post injury. The biochemical and immune-monitoring data will be correlated to corresponding clinical data and data from the German Trauma Registry (TraumaRegister DGU®).
Blood from age- and sex matched healthy volunteers (n=200) will serve as a control group.
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
- 是
入选标准
- 未提供
排除标准
- •age < 18
- •gravidity
结局指标
主要结局
Interleukin-6 (IL-6) plasma concentration
时间窗: 24 hours after polytrauma
Interleukin-6 may indicate the extent of tissue damage and the inflammatory response after trauma
次要结局
- Multiple-Organ-Failure (MOF)(0-28 days after trauma)
- Sepsis(0-28 days after trauma)
- S100 calcium-binding protein B plasma concentration(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
- Creatinine plasma concentration(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
- Bilirubin plasma concentration(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
- Survival(28-day survival)
- Arterial partial oxygen pressure(daily, the first 10 days after trauma)
- Number of microvesicles derived from granulocytes in plasma of patients (as assessed by flow cytometry)(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
- monomeric C-reactive protein(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
- pentameric C-reactive protein(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
- Interleukin-10(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
- Interleukin-1beta(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
- Complement factor C3a(within 30 minutes after polytrauma/ 8 hours/ 24 hours/ 48 hours/ 120 hours/240 hours after polytrauma)
研究者
Markus Huber-Lang
M.D., Professor for Clinical and Experimental Trauma-Immunology
University of Ulm