Interest of Pre-hospital Administration of Lyophilized Plasma to Prevent or Treat Coagulopathy Associated With Post-traumatic Hemorrhagic Shock (PREHO-PLYO Study )
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 22
- 主要终点
- the International Normalized Ratio level (international unit IU) at hospital admission
研究概览
简要总结
In severe bleeding due to trauma, a decrease in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-trauma induced coagulopathy. This study aims to measure the effectiveness of pre-hospital FLYP administration in case of traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic induced coagulopathy.
Study Design
This is a randomized controlled multicenter open label study in two parallel groups.
Eligibility criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood pressure <70 mmHg] or Shock Index >1.1 The patients will receive either FLYP either the usual treatment as given in the recommendations for best practice.
The primary endpoint is the International Normalized Ratio (INR) at hospital admission.
The study must confirm the link between causality of early administration of plasma in improving post-traumatic coagulopathy. The study must show safe usage in out-of-hospital situations and the ability of medical staff to meet the requirements of the health authorities in terms of product use as well as in terms of traceability of the victims and the treatment they received.
详细描述
In severe bleeding due to trauma, a fall in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-traumatic coagulopathy.
This labile blood product has so far only been used in armed conflicts by military medical and surgical units deployed in External Operations (EXOP) to meet the logistical constraints of the operating environment and the need to have, without delay, therapeutic plasma to treat bleeding casualties. Unlike frozen plasma used in hospitals, FLYP is stored at room temperature and is reconstituted in less than 6 mins.
In the civilian world, FLYP could be used by health institutions who have major logistical difficulties which do not allow them to ensure a cold chain of sub-zero temperatures, or in extreme emergency situations with the need for an immediate therapeutic plasma supply. In this second indication, FLYP should be used until the fresh frozen plasma is thawed and available. Its use in pre-hospital situations is also justified due to its immediate availability and storage conditions.
FLYP is sterile and is in powder-form with a residual humidity not exceeding 2%. It is packaged in a sterile and pyrogenic glass vial.
The main objective is to measure the effectiveness of pre-hospital FLYP administration in case of traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic coagulopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •hemorrhagic shock of traumatic origin
- •[Systolic Blood Pressure <70 mmHg] OR [Shock index > 1.1]
排除标准
- •Refusal to participate in the research
- •Unaffiliated to a social welfare system
- •Age under 18 years
- •Privation of person's liberty
- •Person subject to a safeguard measure of justice
- •Pregnancy
- •Allergy known to Amotosalen® and psoralen
- •Contribution factor clotting other than Plyo
- •Patient initialy in cardiac arrest
- •Patient initially in cardiac arrest, followed by resumption of spontaneous circulation
- •People who could not have blood sample (required for the primary endpoint)
研究组 & 干预措施
French Lyophilized Plasma
receives French Lyophilized Plasma with the usual treatment for post traumatic hemorrhagic shock as given in the recommendations for best practice
干预措施: French Lyophilized Plasma (Biological)
Normal Saline Solution
receives Normale Saline Solution with the usual treatment of post traumatic hemorrhagic shock as given in the recommendations for best practice
干预措施: Normale Saline Solution (Biological)
结局指标
主要结局
the International Normalized Ratio level (international unit IU) at hospital admission
时间窗: 1 day
次要结局
- Prothrombin level change (percentage)(48 hours)
- Total Intensive care unit of stay (days)(30 days)
- Thromboelastometry alpha angle (degrees)(1 hour)
- number of plasma units administered at 24 and 48 hours(48 hours)
- Number of RBC Concentrates units administered at 24 and 48 hours(48 hours)
- Fibrinogen level (grams)(1 day)
- the level of coagulation factors (international unit IU) at hospital admission(1 day)
- Thromboelastometry median Maximal Clot Firmness (MCF) time in minutes and seconds(1 hour)
- Number of platelet concentrates units administered at 24 and 48 hours(48 hours)
- Survival(30 days)
- FLYP prehospital usability in civilian population (questionnaire)(30 days)
- Quantity of fibrinogen administered in grams at 24 and 48 hours(48 hours)
- Thromboelastometry median clotting time (CT) (minutes).(1 hour)
- Thromboelastometry median Clot Formation Time (CFT) in minutes and seconds(1 hour)
- Thromboelastometry median maximal lysis (ML) time in minutes ans seconds(1 hour)
- quantity of coagulation factors administered (international units IU)(48 hours)
研究者
Daniel Jost
Emergency Physician - Research Dept
Fire Brigade Of Paris Emergency Medicine Dept