Impact of Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 12
- 主要终点
- Labile blood products transfused in the first 24 hours
研究概览
简要总结
Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of patients with severe trauma) and is associated with increased mortality. ATC is associated with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or 1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies on fast supply of FFP.
To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to use prothrombrin concentrate complex (PCC) as alternative to treat coagulation factor deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen treatment, it is thought that PCC can be efficient in ATC management, while reducing risks associated with massive transfusion.
ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the management of patients at risk of massive transfusion.
Early administration of PPC should optimize patient blood management and therefore reduce blood products transfused within the first 24 hours following a severe trauma.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Primary admission for a severe trauma
- •Out-of-hospital transfusion or RBC transfusion within the first hour following hospital admission
- •Clinical prediction or ABC score (Assessment of Blood Consumption) ≥ 2 of massive transfusion defined by a transfusion of at least 10 CGR during the first 24 hours or 3 CGR during the first hour.
- •Informed consent signed by a relative or emergency procedure
排除标准
- •Cardiac arrest before randomisation
- •Secondary transfer from another hospital (a technical stop is accepted)
- •Post-traumatic lesions out of therapeutic resources with death expected in the hour following hospital admission
- •Anti-coagulation treatment (K anti-vitamine, new oral anticoagulant)
- •Pregnancy
- •Hypersensitivity to active substances or one of the excipients of KANOKAD®
- •Patient treated with an experimental medicine within the last 30 days
- •Decision of therapeutic limitation before randomisation
- •Patient protected by article L1121-7 of the French Public health code.
- •Knowledge of a contraindication to the use of NaCl 0.9% at the dose of 1 mg/kg (hyperchloremia, hypernatremia...)
研究组 & 干预措施
PCC treatment
Conventional strategy for ATC management in addition to of intravenous Pro-Thrombin Concentrate Complex (25IU/kg factor IX)
干预措施: Pro-Thrombin Concentrate Complex (Drug)
Placebo treatment
Conventional strategy for ATC management without PCC (NaCl 0.9%)
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
Labile blood products transfused in the first 24 hours
时间窗: 24 hours following hospital admission
This outcome is measured in number of bags administered
次要结局
- Hospitalisation status(Day 28)
- Cost of the strategy(Day 8 and Day 28)
- RBC (Red Blood Cells) transfused in the first 24 hours(24 hours following hospital admission)
- Platelets transfused in the first 24 hours(24 hours following hospital admission)
- Time to hemostasis(Within the first 24 hours following admission)
- Thrombo-embolic events(ICU stay (an average of 28 days))
- Mortality(24 hours and Day 28)
- ICU-free days(Hospital stay (an average of 28 days))
- Ventilator-Free Days(ICU stay (an average of 21 days))
- Hospital-free days(Within the first 28 days)
- Glasgow Outcome Scale Extended (GOSE)(Day 28)
- FFP transfused in the first 24 hours(24 hours following hospital admission)
- Time to achieve Prothrombin ratio < 1.5(Within the first 24 hours)