Pre-hospital Administration of Fibrinogen Concentrate in Patients With Suspected Trauma-Induced Coagulopathy (PAF-TIC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 主要终点
- Plasma fibrinogen levels
研究概览
简要总结
A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding.
The main endpoints are:
- Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death.
- Administration feasibility of FC within the prehospital setting.
Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.
详细描述
Pre-hospital Administration of Fibrinogen Concentrate in Patients with Suspected Trauma-Induced Coagulopathy (PAF-TIC)
Keywords: Trauma, Coagulopathy, Trauma induced coagulopathy, Fibrinogen, Clot
Introduction Trauma is a leading cause of morbidity and mortality worldwide, with hemorrhage being one of the primary preventable factors contributing to trauma-related deaths. The management of trauma induced coagulopathy (TIC) is a critical aspect of the resuscitation of severely injured patients. Fibrinogen, a key factor in the coagulation cascade, is often rapidly depleted in cases of severe trauma, leading to compromised clot formation and stability. The use of fibrinogen concentrate (FC) in the pre-hospital setting has emerged as a potential intervention to address this issue and improve patient outcomes.
Recent studies have explored the feasibility, efficacy, and safety of administering FC in both prehospital and emergency departments . A randomized feasibility trial demonstrated that early infusion of FC is attainable and can increase plasma fibrinogen concentration during trauma resuscitation, suggesting that larger trials are justified. Similarly, a prospective, randomized, placebo-controlled trial found that prehospital administration of FC improved blood clot stability and protected against early fibrinogen depletion. These findings are supported by a systematic review, which, despite methodological limitations, indicated that FC administration may reduce the need for blood product transfusion.
In a recently published Australian prehospital study, significant coagulopathy was found to develop in 36% of patients transported to trauma centers and could be found in some patients as early as within 30 minutes of injury. Low fibrinogen was the commonest coagulopathy found among trauma patients and was linked to higher in-hospital mortality rates and an increased need for blood transfusions.
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
- Double (Participant, Care Provider)
盲法说明
Masking will be applied to participants during all the stay and to care providers until randomly opaque envelopes are opened.
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 at risk of Trauma Induced Coagulopathy (TIC), with major bleeding or presumed to be bleeding, identified by TIC criteria: mTICCS score > 5 or Shock index > 0.8.
排除标准
- •Known adverse reactions to fibrinogen concentrate (FC)
- •Isolated trauma such as traumatic head injury only
- •Need for cardiopulmonary resuscitation (CPR) on the scene or peri-arrest scenarios
- •Deep hypothermia
- •Age below 18 years
- •Pregnancy
- •Prothrombin time ratio superior equal or superior to 1.2 (PTr>1.2) at the hospital admission
- •Refusal to participate (if the patients are capable of consenting)
研究组 & 干预措施
Standard trauma care
Determined by national guidelines on trauma, elaborated by the National Institute of Medical Emergency and taught to prehospital physicians and nurses at the time of enrollment in prehospital teams to ensure consistency in the treatment of trauma patients nationwide .
干预措施: Standard trauma care (Drug)
Standard trauma care plus administration of fibrinogen concentrate (FC).
The patients assigned to the intervention arm will receive the administration of a fixed dose of 4g fibrinogen, as per previous studies.
干预措施: Fibrinogen concentrate (Drug)
结局指标
主要结局
Plasma fibrinogen levels
时间窗: First 30 minutes on hospital arrival
Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death.
Administration feasibility
时间窗: Prehospital setting
Proportion of Patients Successfully Administered Fibrinogen Concentrate within 60 Minutes Post-Injury. This assessment aims to measure the proportion of eligible trauma patients who receive fibrinogen concentrate (FC) within 60 minutes of their injury. Feasibility will be determined by rigorously evaluating the time it takes to administer the treatment, adherence to the protocol, and any operational challenges encountered. Data will be meticulously compiled to calculate the average time it takes to administer the treatment, the rate of successful protocol adherence, and to identify common barriers to timely FC administration.
次要结局
- Mortality(Day 7 and day 28)
- ICU Length of Stay(Up to 90 days)
- Multiple Organ Failure(Up to 90 days)
- Change of fibrinogen levels(Day 1)
- Change of clot stability upon arrival(First 30 minutes on hospital arrival)
- Clot Formation(Up to 90 days)
- Clot Stability(Up to 90 days)
- Incidence of Thromboembolic events(Up to 7 days after hospital admission)