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Prehospital Resuscitation On Helicopter Study (PROHS)

2015年12月7日 更新者：John Holcomb、The University of Texas Health Science Center, Houston
The Prehospital Resuscitation On Helicopter Study (PROHS) is a pragmatic, multicenter, prospective observational study of air ambulance-based prehospital resuscitation regimens currently utilized at the participating sites. Patients will be enrolled at participating sites that currently have blood products available on air ambulances and other sites that do not. This study will not change the current prehospital standard of care for resuscitation. The primary outcome will be in-hospital mortality and the primary unit of analysis will be the patient. Other outcomes of interest will include time to hemostasis, hospital length-of-stay, number of ventilator-free and ICU-free days, incidence of major surgical procedures, complications (transfusion-related acute lung injury [TRALI], acute kidney injury [AKI], multiple organ failure [MOF], acute respiratory distress syndrome [ARDS], sepsis, intra-abdominal complications, thromboembolic complications, compartment syndromes), lifesaving interventions, the amount and type of blood products and concentrates transfused (including prehospital), wastage of prehospital blood products and concentrates, use of external and internal hemostatic devices, and functional status at discharge/discharge destination.

研究概览

地位

完全的

条件

干预/治疗

详细说明

All patients arriving to the participating center's trauma emergency department via helicopter directly from the scene will be screened and initial data collected. Of that group, all patients who meet the "highest risk" category (based on vital signs, type of injury, use of tourniquet, and/or intubation) or received blood during transport will be followed through "direct observation" through the initial resuscitation period and then indirectly through medical chart review until hospital discharge or 30 days after admission (whichever occurs first).

研究类型

观察性的

注册 (实际的)

1049

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • University of Alabama
    • Arizona
      • Tucson、Arizona、美国、85721
        • University of Arizona
    • California
      • Los Angeles、California、美国、90033
        • University of Southern California, Los Angeles
    • Maryland
      • Baltimore、Maryland、美国、21201
        • University of Maryland School of Medicine
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Medical Center
    • Ohio
      • Cincinnati、Ohio、美国、45221
        • University of Cincinnati
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health and Science University
    • Texas
      • Houston、Texas、美国、77030
        • Memorial Hermann Hospital - Texas Medical Center
    • Washington
      • Seattle、Washington、美国、98104
        • University of Washington- Harborview Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

15年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The target population for this study is trauma patients who are transported to one of the participating Level I trauma centers via air ambulance, directly from the scene, and meet the eligibility criteria.

描述

Inclusion Criteria:

Criteria for "at risk" population

  • Patients with traumatic injuries received directly from the scene via air ambulance service (did not receive a lifesaving intervention at an outside hospital or healthcare facility)
  • Estimated age of 15 or older or greater than/equal to a weight of 50 kg, if age unknown Criteria for "highest risk" population
  • Meet at least one of the following during prehospital care: HR >120 bpm, SBP ≤90 mmHg, penetrating truncal injury, tourniquet application, pelvic binder application or intubation.
  • Received blood products during transport (for those facilities with blood product availability)

Exclusion Criteria:

  • Prisoners (defined as those received directly from a correctional facility.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Received blood products during transport
There is no intervention as this is an observational study. The first group will be the patients that received blood products during the helicopter transport from the scene of the injury per standard of care guidelines at the participating institutions.
其他：无干预
观察性研究
Received crystalloid during transport
There is no study intervention. The second group will be the patients that did not receive blood products during the helicopter transport because blood products are not available or part of the standard of care during flight.
其他：无干预
观察性研究

研究衡量的是什么？

主要结果指标

结果测量
大体时间
In-patient mortality.
大体时间：Up to 30 days
Up to 30 days

其他结果措施

结果测量
措施说明
大体时间
Length of hospital stay
大体时间：Up to 30 days
The total # of hospital days
Up to 30 days
Number of ICU days
大体时间：Up to 30 days
Up to 30 days
Number of Ventilator days
大体时间：Up to 30 days
Up to 30 days
Blood product usage
大体时间：Up to 30 days
Number of RBCs, plasma and platelets used during resuscitation.
Up to 30 days
GOSE score
大体时间：Up to 30 days
GOSE score to measure functional status at time of discharge
Up to 30 days
Number of patients with complications
大体时间：Up to 30 days
Will evaluate the number of patients who experienced common complication following traumatic injury.
Up to 30 days
Number of patients who required hemostatic devices
大体时间：up to 30 days
The use of external and internal hemostatic devices.
up to 30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Texas Health Science Center, Houston

合作者

Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
University of Maryland
University of Alabama at Birmingham
University of Southern California
Oregon Health and Science University
University of Washington
University of Cincinnati
University of Arizona
Resuscitation Outcomes Consortium

调查人员

  • 首席研究员：John Holcomb, M.D.、The University of Texas Health Science Center, Houston

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年1月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2014年10月9日

首先提交符合 QC 标准的

2014年10月20日

首次发布 (估计)

2014年10月23日

研究记录更新

最后更新发布 (估计)

2015年12月8日

上次提交的符合 QC 标准的更新

2015年12月7日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HSC-GEN-14-0735
  • U01HL077863 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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条件

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