Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required
研究概览
简要总结
- Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients
- Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
- Hypo/dysfibrinogenaemia plays an important role in TIC
- Early replacement of fibrinogen may improve outcomes
- Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
- The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
- Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
- It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
- Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
- Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay
- No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients
- Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm
- It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation)
- Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate
- It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult affected by Trauma (>18yrs) and
- •Judged to have significant haemorrhage or
- •Predicted to require significant transfusion with ABC Score ≥ 2 or by treating clinician judgement
排除标准
- •Injury judged incompatible with survival
- •Known objection to blood products
- •Previous Fibrinogen replacement this admission
- •Pre-Trauma Centre fibrinogen replacement
- •Participation in competing study
研究组 & 干预措施
Fibrinogen Concentrate
Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM ≤ A5 10mm]
干预措施: Fibrinogen Concentrate (Drug)
Cryoprecipitate
Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm [FIBTEM A5 ≤ 10mm]
干预措施: Cryoprecipitate (Other)
结局指标
主要结局
Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required
时间窗: 3 Hours
It is anticipated that fibrinogen replacement will occur with 3 hours Fibrinogen replacement will be with either FC or Cryroprecipitate depending on randomisation
Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required
时间窗: 3 Hours
Proportion of patients receiving FC within 30 minutes
Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen
时间窗: 7 Days
Blood sampling will occur for 7 days after admission/randomisation
Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM
时间窗: 7 Days
Blood sampling will occur for 7 days after admission/randomisation
次要结局
- Hospital Length of Stay(1 Year)
- Intensive Care Unit Length of stay(1 Year)
- Duration of bleeding episode or time until surgical control(12 hours)
- Transfusion Requirements(48 hours)
- Adverse Events(1Year)
- All cause Mortality(90 Days)
研究者
Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM
Consultant Intensivist, GCUH ICU
Gold Coast Hospital and Health Service