George Shane, Wake Elizabeth, Jansen Melanie, Roy John, Maconachie Sharon, Paasilahti Anni, Wiseman Greg, Gibbons Kristen, Winearls James
Departments of Emergency Medicine and Children's Critical Care, Gold Coast University Hospital, Southport, Queensland, Australia
School of Medicine and Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia.
BMJ Open. 2022 May 4;12(5):e057780. doi: 10.1136/bmjopen-2021-057780.
Trauma causes 40% of child deaths in high-income countries, with haemorrhage being a leading contributor to death in this population. There is a growing recognition that fibrinogen and platelets play a major role in trauma-induced coagulopathy (TIC) but the exact physiological mechanisms are poorly understood.
This is a prospective multicentre, open-label, randomised, two-arm parallel feasibility study conducted in the emergency departments, intensive care units and operating theatres of participating hospitals. Severely injured children, aged between 3 months and 18 years, presenting with traumatic haemorrhage requiring transfusion of blood products will be screened for inclusion.Sixty-eight patients will be recruited and will be allocated to fibrinogen replacement using fibrinogen concentrate (FC) or cryoprecipitate in a 1:1 ratio. Fibrinogen replacement will be administered to patients with a FIBTEM A5 of ≤10. All other aspects of the currently used rotational thromboelastometry-guided treatment algorithm and damage-control approach to trauma remain the same in both groups.The primary outcome is time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia. Clinical secondary outcomes and feasibility outcomes will also be analysed.
This study has received ethical clearance from the Children's Health Queensland Human Research Ethics Committee (HREC/17/QRCH/78). Equipment and consumables for sample testing have been provided to the study by Haemoview Diagnostics, Werfen Australia and Haemonetics Australia. FC has been provided by CSL Behring, Australia. The funding bodies and industry partners have had no input into the design of the study, and will not be involved in the preparation or submission of the manuscript for publication.The use of viscoelastic haemostatic assays and early fibrinogen replacement has the potential to improve outcomes in paediatric trauma through earlier recognition of TIC. This in turn may reduce transfusion volumes and downstream complications and reduce the reliance on donor blood products such as cryoprecipitate.The use of FC has implications for regional and remote centres who would not routinely have access to cryoprecipitate but could store FC easily. Access to early fibrinogen replacement in these centres could make a significant impact and assist in closing the gap in trauma care available to residents of these communities.Outcomes of this study will be submitted for publication in peer-reviewed journals and submitted for presentation at national and international scientific fora.
NCT03508141.
在高收入国家，创伤导致40%的儿童死亡，出血是这一人群死亡的主要原因。人们越来越认识到纤维蛋白原和血小板在创伤性凝血病（TIC）中起主要作用，但确切的生理机制尚不清楚。
这是一项前瞻性多中心、开放标签、随机、双臂平行可行性研究，在参与医院的急诊科、重症监护病房和手术室进行。将筛查年龄在3个月至18岁之间、因创伤性出血需要输血制品的重伤儿童，以纳入研究。将招募68名患者，并按1:1的比例分配到使用纤维蛋白原浓缩物（FC）或冷沉淀进行纤维蛋白原替代治疗组。纤维蛋白原替代治疗将给予FIBTEM A5≤10的患者。两组中目前使用的旋转血栓弹力图指导治疗方案和创伤损伤控制方法的所有其他方面均保持不变。主要结局是从识别低纤维蛋白原血症到给予纤维蛋白原替代治疗的时间。还将分析临床次要结局和可行性结局。
本研究已获得昆士兰儿童健康人类研究伦理委员会（HREC/17/QRCH/78）的伦理批准。用于样本检测的设备和耗材由澳大利亚Werfen公司的Haemoview Diagnostics和澳大利亚Haemonetics公司提供。FC由澳大利亚CSL Behring公司提供。资助机构和行业合作伙伴未参与研究设计，也不会参与论文的撰写或提交发表。使用粘弹性止血检测和早期纤维蛋白原替代治疗有可能通过更早识别TIC来改善儿童创伤的结局。这反过来可能会减少输血量和下游并发症，并减少对冷沉淀等死血制品的依赖。FC的使用对那些通常无法获得冷沉淀但可以轻松储存FC的地区和偏远中心具有重要意义。在这些中心获得早期纤维蛋白原替代治疗可能会产生重大影响，并有助于缩小这些社区居民可获得的创伤护理差距。本研究的结果将提交给同行评审期刊发表，并在国家和国际科学论坛上进行展示。
NCT03508141。
