RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Multiple Organ Failure (MOF)
研究概览
简要总结
Severe traumatized patients (ISS > 15) admitted to emergency department (ED) University Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient meets the inclusion criteria (T1) and is recruited for the study, a first study related blood sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive fresh frozen plasma (FFP),respectively.
Treatment failure will be registered if bleeding persists and ROTEM parameters do not improve after two times dosages of study drug. In these cases haemostatic rescue therapy will be administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be administered to patients randomized to receive FFP and FFP will be administered to patients of the CFC group.
In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy will be documented and a ROTEM will be performed thereafter.
At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related blood samples are drawn (40mL each).
The indications for transfusion of red blood cells or platelets, administration of antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement are similar for both groups and treatment is performed according to clinical routine.
Besides coagulation management during ED treatment until 24h on ICU, patient's care is not influenced by the study and follows clinical routine.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects =/> 18 years and =/< 80 years
- •Major trauma (ISS > 15)
- •Clinical signs of ongoing bleeding or patients who are at risk for significant haemorrhage assessed and judged by the ED team in charge of patient
- •Presence of coagulopathy defined by ROTEM assays as follows,
- •Patients with concomitant decreased fibrinogen polymerisation (ROTEM® FibTEM A10 of < 7 mm after 10 min)
- •Patients with concomitant decreased coagulation factor levels (ROTEM® ExTEM CT of > 90 sec)
排除标准
- •Lethal injury
- •CPR on the scene,
- •Isolated brain injury, burn injury
- •Avalanche injury
- •Administration of FFP or coagulation factor concentrates before ED admission
- •Delayed (> 6hours after trauma) admittance to ED
- •Known use of oral anticoagulants, or platelet aggregation inhibitors within 5 days before injury
- •Known history of severe allergic reaction to plasma products
- •Known history of congenital hemostasis disturbance, IgA or Protein C deficiency
- •Patients with a history of thromboembolic events or heparin induced thrombocytopenia (HIT) type 2 within the last year
- •Patients with a body weight < 45kg and > 150kg
- •Patients that are known to be pregnant
- •Jehova's Witness
- •Known participation in another clinical trial
- •Patient with known refusal of a participation in this clinical trial
研究组 & 干预措施
Coagulation factor concentrates
干预措施: Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate (Drug)
Fresh Frozen Plasma
干预措施: Fresh Frozen Plasma blood type 0, A, B and AB (Drug)
结局指标
主要结局
Multiple Organ Failure (MOF)
时间窗: Variable until 24h on ICU at the end of the IMP-administration
Difference in the MOF as assessed by the Sequential Organ Failure Assessment score (SOFA) between treatment groups.
次要结局
未报告次要终点
研究者
Univ.-Doz. Dr. Petra Innerhofer
Principal Investigator
Medical University Innsbruck