FOCUS Data Coordinating Center

在美国，每年输注超过1100万个红细胞单位。尽管红色的普遍使用 血细胞输血，输血的阈值尚未得到充分评估。十年前，标准 当血红蛋白水平低于10 g/dl（“10/30 规则”）。对血液安全，特别是艾滋病毒和肝炎方面的血液安全，以及缺乏数据， 支持10 g/dl阈值导致当前的护理标准基于 症状的存在，而不是特定的血红蛋白/红细胞压积水平。然而，没有随机临床试验。 在手术患者中进行的试验，这些试验测试了在患者出现以下症状之前暂停输血的有效性和安全性： 症状或“10/30”输血方法，基础心血管疾病患者证据有限 这种疾病是最有可能因血红蛋白水平降低而产生不良反应的人群。 我们建议进行一项多中心随机试验，以测试是否有一种更积极的输血策略， 维持术后血红蛋白水平高于10 g/dl可改善患者结局， 保守策略，在患者出现贫血症状前停止输血。患者 有资格参加试验的人必须接受过髋部骨折手术修复，并具有术后血红蛋白水平 低于10 g/dl。仅心血管疾病患者将入组研究。 症状输血策略患者将因贫血症状接受血细胞输注， 如果血红蛋白水平低于8 g/dl，也允许输血，但不是必需的。成果将包括 功能恢复{主要结局：60天时在没有人帮助的情况下在房间内行走10英尺的能力 随机分组后）、长期生存率、疗养院安置和术后并发症（住院死亡 或在30天内发生肺炎、心肌梗塞、血栓栓塞、中风）。我们将招募2,600名患者 在3.5年的时间内检测到独立行走能力的丧失从43%降低到36%（相对于16%）， 风险降低），功效约为0.90。 此外，这项研究将测量在这方面重要的医疗错误的频率和95%置信区间。 患者人群。将被测量的医疗错误有：输血错误（输血错误 患者，样本类型和交叉配型标签错误，使用全血代替浓缩红细胞），未能 使用血栓栓塞预防、不正确的抗生素预防、错误部位手术和股骨干骨折。

Over 11 million red blood cell units are transfused in the United States annually. Despite the common use of red blood cell transfusions, the threshold for transfusion has not been adequately evaluated. A decade ago the standard of care was to administer a peri-operative transfusion whenever the hemoglobin level fell below 10 g/dl (the "10/30 rule"). Concerns about the safety of blood, especially with respect to HIV and hepatitis, and the absence of data to support a 10 g/dl threshold led to the current standard of care to administer blood transfusions based on the presence of symptoms and not a specific hemoglobin/hematocrit level. However, there are no randomized clinical trials in surgical patients that have tested the efficacy and safety of withholding blood until the patient develops symptoms or of the "10/30" approachto transfusion and limited evidence for patients with underlyingcardiovascular disease who are at greatest risk of adverse effects from reduced hemoglobin levels. We propose to conduct a multi-center randomized trial to test if a more aggressive transfusion strategy that maintains postoperative hemoglobin levels above 10 g/dl improves patient outcome as compared to a more conservative strategy that withholds blood transfusion until the patient develops symptoms of anemia. Patients eligible for the trial will have undergone surgical repair for a hip fracture and have a postoperative hemoglobin level below 10 g/dl within three days of surgery. Only patients with cardiovascular diseasewill be entered into the study. Symptomatic transfusion strategy patients will receivered blood cell transfusions for symptoms of anemia, although transfusion is also permitted, but not required, if the hemoglobin level falls below 8 g/dl. Outcomes will include functional recovery {primary outcome: ability to walk ten feet across a room without human assistance at 60-days post-randomization), long-term survival, nursing home placement, and postoperative complications (death in hospital or within 30 days, pneumonia, myocardial infarction, thromboembplism, stroke). We will-enroll 2,600 patients over a 3.5-year period to detect a reduction in the loss of ability to walk independently from 43% to 36% (16% relative risk reduction) with power about 0.90. Also, this study will measure the frequency and 95% confidence intervals of medical errors that are important in this patient population. The medical errorsthat will be measuredare: transfusion errors (blood transfusion to the wrong patient, mislabeling of samples for type and cross match, use of whole blood instead of packed red cells), failure to use thromboembolism prophylaxis, incorrect antibiotic prophylaxis, wrong site surgery, and femoral shaft fracture.