Nascimento Bartolomeu, Rizoli Sandro, Rubenfeld Gordon, Lin Yulia, Callum Jeannie, Tien Homer C
Department of Surgery, Tory Regional Trauma Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
J Trauma. 2011 Nov;71(5 Suppl 1):S418-26. doi: 10.1097/TA.0b013e318232e591.
Retrospective reviews have recently shown an survival benefit for adopting a resuscitation strategy that transfuses plasma and platelets at a near 1:1 ratio with red blood cells (RBCs). However, a randomized controlled trial on the topic is lacking. We report on the design and preliminary results of our ongoing randomized control pilot trial (ClinicalTrial.gov NCT00945542).
This is a 2-year feasibility randomized control trial at a single tertiary trauma center. Bleeding trauma patients were randomized to either a laboratory-driven or a formula-driven (1 plasma:1 platelet:1 RBC) transfusion protocols. Feasibility was assessed by analyzing for ability to enroll patients, appropriate activation of transfusion protocols, time to transfusion of each type of blood product, laboratory turnaround time, ratio of blood products transfused, and wastage of blood products.
From July 6, 2009, to May 31, 2010, n = 18 patients were randomized and included in the study. Issues that we noted were the need to do postrandomization exclusions, the need to have rapid and accurate predictors of massive bleeding to enroll patients quickly, and the need to have waived consent for study participation. As well, we noted that the logistics of administering 1:1:1 were formidable and required rapid access to thawed plasma. Similarly, challenges in the control arm of such a study included the turnaround time for obtaining laboratory results.
Despite major challenges, our initial experience suggests that with an organized system, it is possible to prospectively randomize massively bleeding trauma patients. The accomplishment of high ratios of plasma to RBCs is challenging with current thawing methods and unavailability of thawed plasma in Canada. Longer shelf-life for plasma and faster plasma thawing microwaves should overcome some of these obstacles. For a laboratory-guided transfusion protocol, massive transfusion protocols should be in place with faster turnaround time for coagulation tests. Finally, further research on predictors of massive transfusion is needed.
近期的回顾性研究表明，采用红细胞（RBC）与血浆和血小板按接近1:1比例输注的复苏策略可带来生存益处。然而，缺乏关于该主题的随机对照试验。我们报告正在进行的随机对照试验（ClinicalTrial.gov NCT00945542）的设计和初步结果。
这是一项在单一三级创伤中心进行的为期2年的可行性随机对照试验。出血性创伤患者被随机分为实验室驱动或公式驱动（1份血浆:1份血小板:1份RBC）输血方案。通过分析患者入组能力、输血方案的适当启动、每种血液制品的输血时间、实验室周转时间、输注血液制品的比例以及血液制品的浪费情况来评估可行性。
从2009年7月6日至2010年5月31日，n = 18例患者被随机分组并纳入研究。我们注意到的问题包括随机分组后需要排除患者、需要有快速准确的大量出血预测指标以便快速纳入患者以及需要免除研究参与的知情同意。此外，我们注意到实施1:1:1方案的后勤工作艰巨，需要快速获取解冻血浆。同样，此类研究对照组的挑战包括获取实验室结果的周转时间。
尽管面临重大挑战，但我们的初步经验表明，通过一个有组织的系统，有可能对大量出血的创伤患者进行前瞻性随机分组。使用当前的解冻方法以及加拿大缺乏解冻血浆的情况下，实现高比例的血浆与RBC输注具有挑战性。延长血浆保质期和更快的血浆解冻微波炉应能克服其中一些障碍。对于实验室指导的输血方案，应制定大量输血方案，缩短凝血试验的周转时间。最后，需要对大量输血的预测指标进行进一步研究。
