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临床试验/NCT02772653
NCT02772653已完成不适用

Evaluation of Resuscitation Markers in Trauma Patients

Andrea Campos-Serra1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Mortality

研究概览

简要总结

Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients.

This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.

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

  • Pre-hospital Priority 0 protocol activation:
  • Glasgow coma scale < 14
  • Systolic blood pressure < 90 mmHg
  • Respiratory rate < 10 or > 29 breaths per minute
  • Absent peripheral pulses
  • Pre-hospital Priority 1 protocol activation:
  • All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee
  • Flail chest
  • Two or more proximal long-bone fractures
  • Crushed, degloved or mangled extremity
  • Amputation proximal to wrist and ankle
  • Pelvic fracture
  • Open or depressed skull fracture
  • Paralysis

排除标准

  • Hospitalization < 24 hours ( transport of the patient to an other trauma center)
  • Patients transported from an other hospital (first hours of medical support done elsewhere)

结局指标

主要结局

Mortality

时间窗: Through study completion, an average of 1-2 years

Death of the patient

次要结局

  • Blood cell transfusion(Through study completion, an average of 1-2 years)
  • Multiple organ dysfunction (Multiple Organ Dysfunction Score)(Through study completion, an average of 1-2 years)
  • Activation of the Massive blood transfusion protocol(At hospital admission)
  • Arteriographic embolization for bleeding control(Through study completion, an average of 1-2 years)
  • Surgical intervention for bleeding control(Through study completion, an average of 1-2 years)

研究者

发起方
Andrea Campos-Serra
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Andrea Campos-Serra

MD

Corporacion Parc Tauli

研究点 (1)

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