Effects of an Early Prehospital Administration of Tranexamic Acid on Hyperfibrinolysis in Multiple Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Initial state of hyperfibrinolysis
研究概览
简要总结
Severe external and internal bleedings are common in multiple trauma patients. Uncontrollable blood loss is the cause for about one third of all trauma deaths. A number of blood clotting mechanisms are known to be triggered by major blood losses. These mechanisms shall secure the organisms from loosing even more blood. To avoid an overshooting clotting behavior, inhibiting mechanisms occur as well. An important inhibiting (or fibrinolytic) mechanism is the fibrinolysis that is based on the conversion of plasminogen to plasmin. In severe bleeding situations this mechanism tends to overshoot and therewith contributes to the severity of the bleeding. This phenomena is called hyperfibrinolysis and is found in approximately one third of all multiple trauma patients. Mortality rates are increased in these patients. Tranexamic acid is an antifibrinolytic drug that inhibits the conversion from plasminogen to plasmin and therefore is able to limit the effects hyperfibrinolysis. A large study showed positive influence of tranexamic acid on mortality rates and blood loss in severely injured patients, when it was administered in an early clinical setting. In this study we want to answer the question wether a hyperfibrinolysis can be seen in an early prehospital (on the scene) setting and how it is influenced by an early prehospital administration of tranexamic acid.
详细描述
In patients suffering from multiple trauma the initially responding emergency physician on the scene will take a blood sample for thrombelastometry immediately after i.v. access is established. According to the initial trauma life support protocols a number of patients will receive a dose of tranexamic acid during the initial treatment on the scene or during transport to the hospital. A second blood sample will be taken after arrival in the resuscitation area of the hospital. Thrombelastometric measurements will be performed with both blood samples and the extent of hyperfibrinolysis in both samples will be compared. In a second step the outcome of the patients who received tranexamic acid on the scene will be compared to those who did not receive the drug before reaching hospital.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple trauma ISS > 15
- •Age > 18 years
排除标准
- •No informed consent
- •Inclusion to an interventional clinical trial
- •Death of the patient on the scene or before the hospital was reached
- •Delayed thrombelastometric measurement (> 4 hours)
结局指标
主要结局
Initial state of hyperfibrinolysis
时间窗: Minutes after arrival on the scene
State of hyperfibrinolysis quantified by thromelastometry and PAP-Complex (Plasmin-Antiplasmin-Complex) from a blood sample taken a soon as possible on the scene
State of hyperfibrinolysis on hospital admission
时间窗: minutes to hours after incident
State of hyperfibrinolysis quantified by thrombelastometry and PAP-Complex from a blood sample taken as soon as possible after hospital arrival
次要结局
- mortality(90 days)
- substitution of coagulation products(48 hours after hospital admission)
- length of stay intensive care unit (LOS ICU)(one year)
- length of hospital stay(one year)
- transfusion of packed red blood cells(48 hours)
研究者
Dr. med. Nils Kunze
Principal Investigator
University of Göttingen