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临床试验/NCT07046858
NCT07046858招募中不适用

Predictive Accuracy of Platelet Lymphocyte Ratio & Platelet Neutrophil Ratio in Detecting Early Trauma Induced Coagulopathy

Jubilee Mission Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
1. Sensitivity, specificity, positive and negative predictive value

研究概览

简要总结

Observational study to know what is the predictive accuracy of platelet-neutrophil ratio (PNR) and platelet-lymphocyte ratio (PLR) done in patients presenting to ED( emergency department)within 6 hours of trauma; in detecting early trauma induced coagulopathy during hospital admission

详细描述

Trauma has a significant impact on the wellbeing and healthcare for the populations. Millions of patients seek medical help as a result of trauma, with a substantial proportion of patients suffering from life-changing or life-limiting injuries. The leading cause of traumatic death worldwide is road traffic collision, followed by suicide and homicide.(4) The role of platelets in the hemostasis and coagulation is crucial. Platelet interaction with lymphocytes, neutrophils, and monocytes modifies both the innate and adaptive immune responses.Platelets stick to the damaged endothelium and recruit leukocytes to the sites of injury.

Lymphocytes are the major cellular components of the humoral and cell-mediated immune system which include T, B, and natural killer cells. Platelet-lymphocyte ratio (PLR), platelet- neutrophil ratio (PNR) could reflect the balance between the body response to inflammation and immunity mediators Previously, few studies have tested the usefulness of PLR, PNR for predicting the outcomes in stroke , cardiovascular diseases. abdominal trauma, ARDS (Acute Respiratory Distress Syndrome) & sepsis. I would like to do a study, where the results could be utilized in a resource limited hospital , for early referral and the prognostic value of these biomarkers in predicting ETIC in trauma.

The present study hypothesize that the on-admission PLR , PNR values would help early risk stratification and timely management of trauma patients which subsequently improve the outcomes

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

入选标准

  • All patients with trauma AND
  • Presenting to ED within 6 hours of the event AND
  • The ED Physician sends coagulation profile

排除标准

  • Treated with intravenous fluids, drugs, whole blood and blood products elsewhere
  • Patients admitted with a non-mechanical mechanism of injury, specifically drowning, hanging,or burns, as these mechanisms may result in a different biologic response than mechanical trauma
  • Patients on known medications affecting coagulation profile or hemogram
  • Patients with known chronic liver disease, chronic renal failure, malignancy, hematological disorders
  • Patients not consenting for the study

结局指标

主要结局

1. Sensitivity, specificity, positive and negative predictive value

时间窗: 24 hours

PLR and PNR ratio in predicting in-hospital transfusion requirement during index hospital admission.

次要结局

  • Compare the AUROC ( Area Under the Receiver Operating Characteristic Curve) of PLR and PNR ratio in predicting in-hospital transfusion requirement during index hospital admission(24 hours)
  • Compare the AUROC of PLR and PNR ratio in predicting prolonged ventilatory support (>21 days)(24 hours)
  • Compare the incidence of emergent surgery, renal replacement therapy amongst patients developing ETIC and those who do not during the duration of hospital stay or within 30 days (whichever is earlier)(24hours)
  • Compare the length of hospital stay, total number of surgeries, total intensive care days in numbers amongst patients developing ETIC and those who do not during the duration of hospital stay or within 30 days (whichever is earlier)(24hours)

研究者

发起方
Jubilee Mission Medical College and Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amrutha Thotten

Junior Resident

Jubilee Mission Medical College and Research Institute

研究点 (1)

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