External Validation of the Clinical Pre-hospital "Red- Flag" Alert for Activation of Intra-hospital Hemorrhage Control Response in Blunt Trauma. A Prospective Multicentric Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 630
- 主要终点
- Specific intra-hospital severe haemorrhage response
研究概览
简要总结
External validation of the clinical pre-hospital "Red- Flag" alert for activation of intra-hospital hemorrhage control response in blunt trauma.
详细描述
Severe trauma, with a variety of causes, is responsible for more than 9% of the world's population and is the leading cause of preventable mortality among 15-35 year olds. Massive hemorrhage remains the second leading cause of early mortality in those traumatized after head trauma, accounting for about 40% of deaths. In 71% of cases this mortality is pre-hospital without access to rapid medicalization. Intra-hospital mortality is also important.
The main factors explaining this mortality in patients with severe bleeding are delays in recognition and management. The effectiveness of the "trauma systems" and the management channels for severe traumatized injuries are thus generally assessed by the intra-hospital mortality rate. Optimal and early management is therefore essential from the pre-hospital phase.
The treatment of traumatic hemorrhagic shock requires means of local hemostasis, medication management and can go as far as the establishment of massive transfusion protocols (PTM). This type of PTM is activated in about 8% of cases. While it is little practiced in pre-hospital and still debated today, its early hospital establishment is essential.
Rym Hamada et al. highlighted a predictive score "RED-FLAG" of severe hemorrhage in severe traumatized patients requiring the immediate implementation of rapid hemorrhage control (activation of PTM, hemostasis surgery, etc.).
This score is based on 5 clinico-biological items. A score of 2 or more is predictive of an immediate intra-hospital action of hemostasis. In France, several networks are organized around centers 15 and hospitals specialized in the management of severe traumatized, from alert to definitive treatment, in accordance with the international recommendations in force.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Adult patients (More than 18 yo)
- •Regulated by the medical regulation centers (SAMU - centres 15) of the hospitals of Angers (SAMU 49), Rennes (SAMU 35), Le Mans (SAMU 72), Tours (SAMU 37), Laval (SAMU 53) and Chambéry (SAMU 73)
- •Patients with severe trauma classified as A or B
- •And benefiting respectively from hospital support in trauma centers
- •Not subject to limitation of active therapeutics
- •Member or beneficiary of a social security scheme
- •Exclusion criteria:
- •Patients with Not Considered Severe Trauma (Not A, B or C) after pre-hospital medical assessment
- •Patient objecting to participating in research
排除标准
- 未提供
结局指标
主要结局
Specific intra-hospital severe haemorrhage response
时间窗: 24 hours
The main evaluation criterion is defined, as in the initial study by Hamada et al., by the presence of intrahospital criteria for severe hemorrhage justifying an immediate intrahospital action of hemostasis, defined by: * Red Blood Cell Concentrate transfusion required upon arrival at trauma center * Transfusion of at least 4 CGR within the first 6 hours of hospital management * Lactacidemy 5 mmol/L at first blood collection * Need for hemostasis surgery or radiology interventional prior to completion of a pan-body CT lesion assessment * Death from hemorrhagic shock within first 24 hours admission The ability of the RED-FLAG score to detect patients with severe hospital bleeding requiring immediate hemostasis action (as defined above) will be assessed by determining the area under the curve and its 95% CI of the ROC curve of this score.
次要结局
- Comparison of the two RED-FLAG and BATT scores(24 hours)