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临床试验/NCT04216225
NCT04216225已完成不适用

Prospective Observational Multi-center Analysis of Pre-hospital Tourniquet in Extremity Injury

Methodist Health System2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Incidence of arrival in shock

研究概览

简要总结

2.1. Objective:

• Primary Objective: To compare outcomes of patients with extremity injuries presenting with or without pre-hospital tourniquet placement.

2.2. Study Outcome Measures

  • Primary Outcome: Incidence of arrival in shock (SBP <90)
  • Secondary Outcomes: Demographics, comorbidities, mechanism of injury, cause of injury, diagnosis codes, procedure codes, Injury Severity Scale, Abbreviated Injury Scale, operative management vs. non-operative management, radiologic findings, pathologic findings, tourniquet effectiveness (as determined both subjectively by trauma surgeon and objectively by presence vs. absence of pulse below level of tourniquet application), total number of units of blood products transfused within first 24 hrs, total number of units of blood products for index admission, type of blood products or other fluid given, hospital length of stay, ICU length of stay, ventilator days, infectious complications, other complications, discharge disposition, 24 hr mortality, overall mortality.

详细描述

This is a prospective, observational study. All patients who present to the participating ED's who meet inclusion/exclusion criteria will be identified by the treating trauma surgeons. Data collected will include basic patient demographics, data regarding the patient's injuries, data regarding tourniquet use, and data regarding outcomes. Please see the attached data collection tool for specifics (Appendix 12.1). Data will be collected prospectively in an observational manner using the data collection tool. Data collected on individual collection sheets will be de-identified. We plan to complete the data collection and analysis by 01\01\2021.

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

  • ≥ 18 y/o Patients with extremity injuries
  • With a tourniquet in place OR
  • Who the treating physician deems could have benefited from tourniquet placement

排除标准

  • Prisoners
  • Pregnant women
  • Patients with non-traumatic bleeding requiring tourniquet use

结局指标

主要结局

Incidence of arrival in shock

时间窗: First 24 hours .

(Systolic Blood Pressure \<90 mmHg (Millimeter of mercury))

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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