A Randomized Controlled Pilot Trial of Modified Whole Blood versus Component Therapy in Severely Injured Patients Requiring Large Volume Transfusions
A Randomized Controlled Pilot Trial of Modified Whole Blood versus Component Therapy in Severely Injured Patients Requiring Large Volume Transfusions
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DOI：
10.1097/sla.0b013e3182a4ffa0
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发表时间：
2013-10-01
影响因子：
9
通讯作者：
Holcomb, John B.
中科院分区：
文献类型：
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作者：
Cotton, Bryan A.;Podbielski, Jeanette;Holcomb, John B.
目的：确定与成分（COMP）治疗相比，使用改良全血（mWB）对严重受伤患者进行复苏是否会减少总体输血量。背景：几十年来，全血（WB）是失血性休克患者复苏的主要产品。 20 世纪 70 年代血库取得巨大进步后，献血中心开始向医院提供单独成分 [红细胞 (RBC)、血浆、血小板]，并取消了 WB 作为可用产品的情况。然而，在此之前，没有对创伤患者的疗效或止血潜力进行研究。方法：对严重受伤患者进行的单中心随机试验，预测需要大量输血。孕妇、囚犯、18 岁以下或全身表面积烧伤 (TBSA) 超过 20% 的患者被排除在外。患者抵达后立即被随机分配接受 mWB (1 U mWB) 或 COMP 治疗（1 U RBC+ 1 U 血浆）。每组还每 6 U mWB 或 6 U RBC + 6 U 血浆接受 1 U 血小板（单采或预混合随机供体）。该研究是在知情同意例外情况下进行的（食品和药物管理局 21 联邦法规 [CFR] 50.24）。主要结果是 24 小时输血量。结果：总共 107 名患者在 14 个月内被随机分配（55 mWB，52 COMP 治疗）。人口统计、到达生命体征或实验室值、损伤严重程度或机制没有差异。各组之间的输血相似（意向治疗分析）。然而，排除严重脑损伤患者（敏感性分析）后，WB组接受的24小时红细胞（中位数3 vs 6，P = 0.02）、血浆（4 vs 6，P = 0.02）、血小板（0 vs 3，P = 0.09）和总乘积（11 vs 16，P = 0.02）较少。结论：与COMP治疗相比，WB并未减少输血量预计将接受大量输血的重伤患者。然而，在敏感性分析（没有严重脑损伤的患者）中，mWB 的使用显着减少了输血量，达到了这项初步试点研究的预定终点。
Objectives: To determine whether resuscitation of severely injured patients with modified whole blood (mWB) resulted in fewer overall transfusions compared with component (COMP) therapy.Background: For decades, whole blood (WB) was the primary product for resuscitating patients in hemorrhagic shock. After dramatic advances in blood banking in the 1970s, blood donor centers began supplying hospitals with individual components [red blood cell (RBC), plasma, platelets] and removed WB as an available product. However, no studies of efficacy or hemostatic potential in trauma patients were performed before doing so.Methods: Single-center, randomized trial of severely injured patients predicted to large transfusion volume. Pregnant patients, prisoners, those younger than 18 years or with more than 20% total body surface area burns (TBSA) burns were excluded. Patients were randomized to mWB (1 U mWB) or COMP therapy (1 U RBC+ 1 U plasma) immediately on arrival. Each group also received 1 U platelets (apheresis or prepooled random donor) for every 6 U of mWB or 6 U of RBC + 6 U plasma. The study was performed under the Exception From Informed Consent (Food and Drug Administration 21 code of federal regulations [CFR] 50.24). Primary outcome was 24-hour transfusion volumes.Results: A total of 107 patients were randomized (55 mWB, 52 COMP therapy) over 14 months. There were no differences in demographics, arrival vitals or laboratory values, injury severity, or mechanism. Transfusions were similar between groups (intent-to-treat analysis). However, when excluding patients with severe brain injury (sensitivity analysis), WB group received less 24-hour RBC (median 3 vs 6, P = 0.02), plasma (4 vs 6, P = 0.02), platelets (0 vs 3, P = 0.09), and total products (11 vs 16, P = 0.02).Conclusions: Compared with COMP therapy, WB did not reduce transfusion volumes in severely injured patients predicted to receive massive transfusion. However, in the sensitivity analysis (patients without severe brain injuries), use of mWB significantly reduced transfusion volumes, achieving the prespecified endpoint of this initial pilot study.