Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
研究概览
简要总结
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Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in paediatric trauma patients
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Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
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Hypo/dysfibrinogenaemia plays an important role in TIC
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Early replacement of fibrinogen may improve outcomes
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Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
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The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
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Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
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It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
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Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
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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
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No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in paediatric trauma patients 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child affected by trauma (3 months to 18 years)
- •Judged to have significant haemorrhage OR predicted to require significant transfusion by the treating clinician
- •Activation of Local MHP or transfusion of emergency red blood cells (Pre-hospital or at Trauma Centre)
排除标准
- •Injury judged incompatible with survival
- •Randomisation unable to occur within 6 hours of hospital admission
- •Known personal or parental objection to blood products
- •Known coagulation disorder (i.e. haemophilia, von Willebrand disease)
- •Previous dedicated fibrinogen replacement this admission
- •Pre-Trauma Centre dedicated fibrinogen replacement
- •Participation in competing study
研究组 & 干预措施
Fibrinogen Concentrate
Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 60mg/kg FC FIBTEM A5 1-4mm = 50mg/kg FC FIBTEM A5 5-6mm = 40mg/kg FC FIBTEM A5 7-8mm = 30mg/kg FC FIBTEM A5 9-10mm = 20mg/kg FC
干预措施: Fibrinogen Concentrate (Drug)
Cryoprecipitate
Fibrinogen Replacement using Cryoprecipitate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 6ml/kg Cryoprecipitate FIBTEM A5 1-4mm = 5ml/kg Cryoprecipitate FIBTEM A5 5-6mm = 4ml/kg Cryoprecipitate FIBTEM A5 7-8mm = 3ml/kg Cryoprecipitate FIBTEM A5 9-10mm = 2ml/kg Cryoprecipitate
干预措施: Cryoprecipitate (Drug)
结局指标
主要结局
Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
时间窗: 3 Hours
Time to fibrinogen replacement
次要结局
- Transfusion Requirements(Up to 48 hours after Trauma Unit presentation)
- Adverse Events(1 Year)
- Duration of bleeding episode or time until surgical control(It is anticipated that haemorrhage control will be achieved within 12 hours)
- Intensive Care Unit LOS(1 Year)
- All Cause Mortality(Up to 90 Days)
- Functional Outcomes GOS-E Paediatrics(Up to 90 Days)
- Hospital LOS(1 Year)
研究者
Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM
Dr James Winearls, Consultant Intensivist GCUH
Gold Coast Hospital and Health Service