FOCUS Data Coordinating Center

描述（来自应用程序）：在美国有超过1100万单位的输血。尽管红细胞输注的普遍使用，输血的阈值尚未得到充分评估。十年前的护理标准是每当血红蛋白水平低于10 g/dl时进行围手术期输血（“10/30规则”）。对血液安全性的担忧，特别是关于HIV和肝炎，以及缺乏支持10 g/dl阈值的数据，导致目前的标准治疗是基于症状的存在而不是特定的血红蛋白/红细胞压积水平进行输血。然而，目前还没有在手术患者中进行的随机临床试验，来测试在患者出现症状或10/30之前暂停输血的有效性和安全性。 输血方法和有限的证据表明，患有基础心血管疾病的患者血红蛋白水平降低的不良反应风险最大。我们建议进行一项多中心随机试验，以测试与在患者出现症状前停止输血的保守策略相比，将术后血红蛋白水平维持在10 g/dl以上的更积极的输血策略是否能改善患者的预后 贫血症。符合试验条件的患者将接受髋关节骨折手术修复，并在手术后三天内具有低于10 g/dl的术后血红蛋白水平。仅心血管疾病患者将入组研究。症状输血策略患者将接受红细胞输注治疗贫血症状，尽管 如果血红蛋白水平低于8 g/dl，也允许输血，但不要求输血。结局将包括功能恢复（主要结局：随机分组后60天在没有人类帮助的情况下在房间内行走10英尺的能力）、长期生存、疗养院安置和术后并发症（住院或30天内死亡，肺炎， 心肌梗塞、血栓栓塞、中风）。我们将在3.5年的时间内随机选择2,600名患者，以检测独立行走能力丧失从43%降低到36%（相对风险降低16%），功效约为0.90。此外，本研究将测量该患者人群中重要医疗错误的频率和95%置信区间。将被衡量的医疗错误是：输血错误（输血到 错误的患者、样本类型和交叉配型标签错误、使用全血而不是浓缩红细胞）、未使用血栓栓塞预防、不正确的抗生素预防、错误的手术部位和股骨干骨折。

DESCRIPTION (FROM THE APPLICATION): Over 11 million units are transfused in the United States. 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 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 the 10/30 approach to transfusion and limited evidence for patients with underlying cardiovascular disease 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 disease will be entered into the study. Symptomatic transfusion strategy patients will receive red 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, thromboembolism, stroke). We will randomize 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 the medical errors that are important in this patient population. The medical errors that will be measured are: 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.