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临床试验/NCT04233723
NCT04233723Unknown不适用

Effect of Severe Trauma on Programmed Death Molecule (PD1) and Its Legend (PD1/L1) on T Lymphocytes and Correlation With Mortality

Assiut University0 个研究点目标入组 100 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Measuring standard deviations of biomarkers of severe injury by comparing T lymphocytes and programmed cell death molecules and its relation with mortality.

研究概览

简要总结

Unlike neuro-endocrine response to trauma; posttraumatic immune alterations are not easily carried out at bedside. The majority of trials were conducted in the intensive care usually hours to days post injury.

In this trial the investigators sought assess the immune responses during emergency department trauma resuscitation by looking at the biomarkers of severe injury by comparing T lymphocytes and programmed cell death molecules and its relation with mortality.

详细描述

Trauma is a major healthcare problem with a high mortality rate that might be caused by immune-suppression.

Trauma initiates an immunosuppressive response which is contributor tocell damage and could be a marker of multi organ failure and mortality.

Programmed cell death receptor-1 (PD-1) and programmed cell death receptor ligand-1 (PD-L1), which are co-inhibitory receptor molecules, may participate in trauma-induced immune-suppression.

Both sterile and infected trauma induce the systemic inflammatory response syndrome (SIRS), originally defined by pyrexia, tachycardia, hyperventilation and neutrophilia, the latter responding poorly to pathogens. (10) Accompanying these changes is a decrease in circulating basophil, eosinophil and natural killer precursors, which further weakens systemic immunity.

Apoptosis (Programmed Cell Death):

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • Adult trauma patients with blunt or penetrating injury.
  • Major injury:
  • Injury severity score > 15
  • Drop in hematocrit > 10 points
  • Transfusion of more than 6-10 units of packed RBCs
  • Serum lactate > 3 mmol/L
  • Mean arterial blood pressure ≤ 60 mmHg and/or systolic arterial blood pressure ≤ 90 mmHg.
  • Patients admitted to the ED within 6 hours after the onset of trauma

排除标准

  • age less than 18 years;
  • patients who died within 2 days of the onset of trauma;
  • patients who declined to consent;
  • Known pregnancy.
  • Patients with limb ischemia or peripheral vascular occlusion.
  • Patients admitted to the emergency trauma department after 6 hours of the trauma event.
  • Preexisting conditions as severe cardiovascular disease, uncontrolled hemorrhage.

结局指标

主要结局

Measuring standard deviations of biomarkers of severe injury by comparing T lymphocytes and programmed cell death molecules and its relation with mortality.

时间窗: 48 hours

Results for normally distributed continuous variables will be expressed as mean value, standard deviation and inter-quartile range. Categorical data and dichotomous variables will be shown as number and percentage. Comparisons of continuous variables will be performed using independent t-test. Proportions will be compared with chi-square test.

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

RRHennis

principal investigator

Assiut University

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