BackgroundThe hemoglobin threshold for transfusion of red blood cells in patients withacute gastrointestinal (GI) bleeding is controversial. We compared theefficacy and safety of a restrictive transfusion strategy with those of aliberal transfusion strategy.MethodsObjective: The objective was to prove that the restrictivethreshold for red blood cell transfusion in patients with acute upper GIbleeding (UGIB) was safer and more effective than a liberal transfusionstrategy.Design: A single-center, randomized controlled trial wasconducted.Setting: Patients with GI bleeding were admitted to the de la SantaCreu i Sant Pau hospital in Barcelona, Spain.Subjects: The subjects were adult intensive care unit patientsadmitted with high clinical suspicion of UGIB (hematomemesis, melena, orboth). Patients were excluded if they had massive exsanguinating bleeding,acute coronary syndrome, symptomatic peripheral vascular disease,stroke/transient ischemic attack, transfusion within the previous 90 days,recent trauma or surgery, lower GI bleeding, or a clinical Rockall score of0 with hemoglobin higher than 12 g/dL.Intervention: A total of 921 patients with severe acute UGIB wereenrolled. Of these, 461 were randomly assigned to a restrictive strategy(transfusion when the hemoglobin level fell to below 7 g/dL) and 460 to aliberal strategy (transfusion when the hemoglobin fell to below 9 g/dL).Random assignment was stratified according to the presence or absence ofliver cirrhosis.Outcomes: The primary outcome was rate of death from any causewithin the first 45 days. Secondary outcomes were further bleeding, definedas hematemesis or melena with hemodynamic instability or hemoglobin decreaseof 2 g/dL or more, and in-hospital complications.ResultsIn total, 225 patients assigned to the restrictive strategy (51%) and 65assigned to the liberal strategy (15%) did not receive transfusions(P <0.001). The probability of survival at 6 weeks washigher in the restrictive-strategy group than in the liberal-strategy group(95% versus 91%; hazard ratio (HR) for death with restrictive strategy,0.55; 95% confidence interval (CI) 0.33 to 0.92; P = 0.02). Furtherbleeding occurred in 10% of the patients in the restrictive-strategy groupand in 16% of the patients in the liberal-strategy group (P =0.01), and adverse events occurred in 40% and 48%, respectively (P= 0.02). The probability of survival was slightly higher with therestrictive strategy than with the liberal strategy in the subgroup ofpatients who had bleeding associated with a peptic ulcer (HR 0.70, 95% CI0.26 to 1.25) and was significantly higher in the subgroup of patients withcirrhosis and Child-Pugh class A or B disease (HR 0.30, 95% CI 0.11 to 0.85)but not in those with cirrhosis and Child-Pugh class C disease (HR 1.04, 95%CI 0.45 to 2.37). Within the first 5 days, the portal-pressure gradientincreased significantly in patients assigned to the liberal strategy(P = 0.03) but not in those assigned to the restrictivestrategy.ConclusionsCompared with a liberal transfusion strategy, a restrictive strategysignificantly improved outcomes in patients with acute UGIB.
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机译：背景急性胃肠道（GI）出血患者的红细胞输血的血红蛋白阈值存在争议。我们比较了限制性输血策略和自由输血策略的有效性和安全性。方法目的：目的是证明急性上消化道出血（UGIB）患者的红细胞输注阈值比自由输血策略更安全，更有效。设计：进行了一项单中心，随机对照试验设置：胃肠道出血患者入院于西班牙巴塞罗那的de la SantaCreu i Sant Pau医院受试者：受试者为成人重症监护病房患者，临床上高度怀疑UGIB（血肿，黑便或两者）。如果患者出现大量出血性出血，急性冠状动脉综合征，症状性周围血管疾病，中风/短暂性脑缺血发作，在过去90天内输血，最近的创伤或手术，胃肠道出血较少或临床Rockall评分为0且血红蛋白更高超过12 g / dL。干预：总共921例重症急性UGIB患者入组。其中461例被随机分配为限制性策略（当血红蛋白水平降至7 g / dL以下时输血），460例被分配为自由策略（当血红蛋白水平降至9 g / dL以下时输血）。结果：主要结果是头45天内因任何原因导致的死亡率。次要结局为进一步出血，定义为呕血或黑便，血流动力学不稳定或血红蛋白降低2 g / dL或以上，以及院内并发症。结果总共有225例患者被分配为限制性策略（51％），65例为自由策略15％）没有接受输血（P <0.001）。限制性策略组6周生存率高于自由策略组（95％比91％;限制性策略致死危险比（HR）为0.55; 95％置信区间（CI）为0.33至0.92; P = 0.02）。限制性策略组10％的患者发生出血，自由策略组16％的患者发生出血（P = 0.01），不良事件分别发生40％和48％（P = 0.02）。在有消化性溃疡出血的患者亚组中，采用限制性策略生存的可能性比采用自由策略略高（HR 0.70，95％CI0.26至1.25），而在肝硬化和肝硬化患者中则显着更高。 Child-Pugh A级或B级疾病（HR 0.30，95％CI 0.11至0.85），但对于肝硬化和Child-Pugh C级疾病（HR 1.04，95％CI 0.45至2.37）不适用。在开始的5天内，分配给自由策略的患者的门静脉压力梯度显着增加（P = 0.03），但分配给限制性策略的患者的门静脉压力梯度却没有增加。 。
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