From the Section for Transfusion Medicine, Capital Region Blood Bank, Copenhagen University Hospital, Rigshospitalet, Denmark.
Department of Anesthesia, Centre of Head and Orthopedics, Copenhagen University Hospital, Rigshospitalet, Denmark.
Anesth Analg. 2018 Oct;127(4):920-927. doi: 10.1213/ANE.0000000000003545.
Thoracic aorta dissection is an acute critical condition associated with shock-induced endotheliopathy, coagulopathy, massive bleeding, and significant morbidity and mortality. Our aim was to compare the effect of coagulation support with solvent/detergent-treated pooled plasma (OctaplasLG) versus standard fresh frozen plasma (FFP) on glycocalyx and endothelial injury, bleeding, and transfusion requirements.
Investigator-initiated, single-center, blinded, randomized clinical pilot trial of adult patients undergoing emergency surgery for thoracic aorta dissection. Patients were randomized to receive OctaplasLG or standard FFP as coagulation factor replacement related to bleeding. The primary outcome was glycocalyx and endothelial injury. Other outcomes included bleeding, transfusions and prohemostatics at 24 hours, organ failure, length of stay in the intensive care unit and in the hospital, safety, and mortality at 30 and 90 days.
Fifty-seven patients were included to obtain 44 evaluable on the primary outcome. The OctaplasLG group displayed significantly reduced damage to the endothelial glycocalyx (syndecan-1) and reduced endothelial tight junction injury (sVE-cadherin) compared to standard FFP. In the OctaplasLG group compared to the standard FFP, days on ventilator (1 day [interquartile range, 0-1] vs 2 days [1-3]; P = .013), bleeding during surgery (2150 [1600-3087] vs 2750 [2130-6875]; P = .046), 24-hour total transfusion and platelet transfusion volume (3975 mL [2640-6828 mL] vs 6220 mL [4210-10,245 mL]; P = .040, and 1400 mL [1050-2625 mL] vs 2450 mL [1400-3500 mL]; P = .027), and goal-directed use of prohemostatics (7/23 [30.4%] vs 13/21 [61.9%]; P = .036) were all significantly lower. Among the 57 patients randomized, 30-day mortality was 20.7% (6/29) in the OctaplasLG group and 25% (7/28) in the standard FFP group (P = .760). No safety concern was raised.
In this randomized, clinical pilot trial of patients undergoing emergency surgery for thoracic aorta dissections, we found that OctaplasLG reduced glycocalyx and endothelial injury, reduced bleeding, transfusions, use of prohemostatics, and time on ventilator after surgery compared to standard FFP. An adequately powered multicenter trial is warranted to confirm the clinical importance of the findings.
胸主动脉夹层是一种与休克诱导的内皮病、凝血障碍、大量出血以及显著发病率和死亡率相关的急性危急病症。我们的目的是比较凝血支持与溶剂/去污处理的混合血浆（OctaplasLG）与标准新鲜冷冻血浆（FFP）对糖萼和内皮损伤、出血和输血需求的影响。
这是一项由研究者发起、单中心、盲法、随机临床试验，纳入了接受紧急胸主动脉夹层手术的成年患者。患者根据出血情况被随机分配接受 OctaplasLG 或标准 FFP 作为凝血因子替代物。主要结局是糖萼和内皮损伤。其他结局包括 24 小时时的出血、输血和促凝剂、器官衰竭、重症监护病房和住院时间、安全性以及 30 天和 90 天时的死亡率。
纳入了 57 例患者，以获得 44 例可评估主要结局的患者。与标准 FFP 相比，OctaplasLG 组显示内皮糖萼（连接蛋白-1）和内皮紧密连接损伤（sVE-钙黏蛋白）的损伤明显减少。与标准 FFP 相比，在 OctaplasLG 组中，呼吸机使用天数（1 天 [四分位距，0-1] 与 2 天 [1-3]；P =.013）、手术期间出血（2150 [1600-3087] 与 2750 [2130-6875]；P =.046）、24 小时总输血和血小板输血量（3975 mL [2640-6828] 与 6220 mL [4210-10245]；P =.040，和 1400 mL [1050-2625] 与 2450 mL [1400-3500]；P =.027）以及目标导向使用促凝剂（7/23 [30.4%] 与 13/21 [61.9%]；P =.036）均明显更低。在随机分组的 57 例患者中，OctaplasLG 组的 30 天死亡率为 20.7%（6/29），标准 FFP 组为 25%（7/28）（P =.760）。未发现安全性问题。
在这项对接受紧急胸主动脉夹层手术的患者进行的随机临床试验中，我们发现与标准 FFP 相比，OctaplasLG 可减少糖萼和内皮损伤、减少出血、输血、促凝剂使用以及术后呼吸机使用时间。需要一项充分的多中心试验来证实这些发现的临床重要性。
