FOCUS Data Coordinating Center

描述(来自申请)：在美国有超过1100万个单位的输血。尽管红细胞输注已得到普遍应用，但输血阈值还没有得到充分的评估。十年前的护理标准是，只要血红蛋白水平降至10g/dl以下，就进行围手术期输血(10/30规则)。对血液安全性的担忧，特别是对艾滋病毒和肝炎的担忧，以及缺乏支持10g/dl阈值的数据，导致了目前的护理标准，即根据症状的出现而不是特定的血红蛋白/红细胞压积水平来管理输血。然而，目前还没有对外科患者进行随机临床试验，以测试在患者出现症状或10/30之前不放血的有效性和安全性。 对于潜在的心血管疾病患者，输血方法和证据有限，降低血红蛋白水平产生不良反应的风险最大。我们建议进行一项多中心随机试验，以测试与更保守的策略相比，将术后血红蛋白水平维持在10g/dl以上的更积极的输血策略是否会改善患者的预后，直到患者出现症状时才输血。 贫血的症状。符合试验条件的患者将接受髋部骨折的手术修复，并在手术后三天内血红蛋白水平低于10g/dl。只有患有心血管疾病的患者才会进入这项研究。有症状的输血策略患者将接受红细胞输注以治疗贫血症状，尽管 如果血红蛋白水平低于8g/dl，也可以输血，但不是必须的。结果将包括功能恢复(主要结果：随机后60天在没有人工帮助的情况下步行10英尺的能力)、长期生存、疗养院安置和术后并发症(在医院或30天内死亡，肺炎， 心肌梗塞、血栓栓塞症、中风)。我们将在3.5年内对2600名患者进行随机抽样，以检测独立行走能力的丧失从43%下降到36%(相对风险降低16%)，功率约为0.90。此外，这项研究将测量医疗差错的频率和95%的可信区间，这些差错在这一患者群体中是重要的。将测量的医疗差错包括：输血差错(向 错误的患者，错误的类型和交叉匹配的样本标签，使用全血而不是压缩的红细胞)，未能使用血栓栓塞症预防，错误的抗生素预防，错误的部位手术，以及股骨干骨折。

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.