FOCUS Hip Fracture Transfusion Trial: Delirium and Other Cognitive Outcomes

FOCUS 髋部骨折输血试验：谵妄和其他认知结果

• 批准号: 7766220
• 负责人: ANN L GRUBER-BALDINI
• 金额: $ 37.95万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-02-12 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7766220
• 关键词: Academic Medical Centers; Acute; Admission activity; Affect; Age; Ancillary Study; Anemia; Attention; Baltimore; Blood; Blood Transfusion; Boston; Brain; British Columbia; Canada; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Clinic; Clinical Trials; Cognitive; Confusion; Conscious; Day Surgery; Delirium; Dentistry; Disease; Education; Elderly; Equation; Foundations; Fracture; Funding; Future; Health Sciences; Hemoglobin; Hemoglobin concentration result; Hemorrhage; Hip Fractures; Hospitalization; Hospitals; Human; Intention; Intervention; Israel; Lead; Life; Location; London; Lower Extremity; Maryland; Measurement; Measures; Medical center; Medicine; Memory impairment; Metric; Morbidity - disease rate; National Heart, Lung, and Blood Institute; New Brunswick; New Jersey; New York; Nursing Homes; Operative Surgical Procedures; Outcome; Parents; Patients; Pattern; Persons; Physiology; Postoperative Period; Presbyterian Church; Protocols documentation; Randomized; Randomized Clinical Trials; Recording of previous events; Recovery; Recovery of Function; Recruitment Activity; Research; Risk; Risk Factors; Role; Sample Size; Sampling; Severities; Site; Symptoms; Testing; Texas; Time; Transfusion; Universities; University Hospitals; Virginia; Vulnerable Populations; Walking; Wood material; acute coronary syndrome; cardiovascular disorder risk; cardiovascular risk factor; clinical research site; cognitive function; design; experience; foot; functional outcomes; high risk; improved; instrumental activity of daily living; interest; medical schools; mortality; performance site; prevent; primary outcome; repaired; secondary outcome

DESCRIPTION (provided by applicant): Proposed is an ancillary study to the Transfusion Therapy Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS) to examine the impact of the hemoglobin interventions on delirium in a sub-sample of 200 subjects (100 per randomization group). FOCUS is a randomized clinical trial of 2,000 hip fracture patients funded by the NHLBI designed to test the hypothesis that a higher blood transfusion threshold does not improve functional recovery or reduce morbidity and mortality. Patients are randomized to receive enough blood to maintain hemoglobin level >10 g/dL versus receiving transfusion if hemoglobin level is less than 8 g/dL or when symptoms of anemia develop (symptomatic strategy). This ancillary study will extend our understanding the effects of transfusion thresholds on delirium. The primary aims are to determine whether a symptomatic transfusion strategy (8 g/dL) is associated with more severe symptoms of acute delirium during hospitalization compared to a 10 g/dL transfusion strategy. Secondary aims will examine whether the transfusion randomization also affects persistence of delirium symptoms at 30 days post-discharge and will examine the association of in hospital and 30-day persistence of delirium symptoms on later functional outcomes. The 200 subjects will be recruited from 16 FOCUS sites. FOCUS subjects are hip fracture patients, ages 50+, with a history of CVD or cardiovascular risk factors, and who have a post-operative hemoglobin level less than 10 g/dL within 3 days of surgery. Subjects will be assessed for delirium pre- randomization, for up to 3 days post-randomization (in-hospital), and at 30 days post-randomization. Outcomes include 30- and 60-day morbidity, mortality, lower extremity function, instrumental activities of daily living, and discharge location. Our sample size projections seek to detect medium effects. Generalized Estimation Equations will be used to evaluate the longitudinal patterns between the two groups of 100 hip fracture patients using all measurement time points. Intention to treat principles will be followed in the analyses. Analyses will be done by randomization group, and sensitivity analyses will examine whether there are differences in important confounders between groups and their effects on the analyses. PERFORMANCE SITE(S): University of Maryland Baltimore, Baltimore, MD University of Medicine and Dentistry of New Jersey, New Brunswick, NJ Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA Baltimore Research & Education Foundation, Perry Point, MD Clinical Sites: Robert Wood Johnson Hospital, New Brunswick, NJ London Health Science Center, Toronto, Canada Mayo Clinic, St. Mary's Hospital, Rochester, MI Sunny Brook, Toronto, Canada Johns Hopkins Bayview Medical Center, Baltimore MD Cooper University Hospital, Camden, NJ University of Ottowa, Ottowa, Canada Eastern Virginia Medical School, Norfolk, VA Columbia University Medical Center, New York, NY New York Presbyterian Hospital, New York, NY Cleveland Clinic, Cleveland, OH Lahey Clinic Medical Center, Burlington, MA Emory University, Atlanta, GA Texas Technical, Lubbock, TX Maimondes Medical Center, Brooklyn, NY University of British Columbia, Vancouver, Canada This is an ancillary study to a large clinical trial (R01 HL073958) that looks at different levels of blood transfusion to treat blood loss after hip fracture surgery, in patients who also have cardiovascular disease or cardiovascular risk factors. This ancillary study examines whether transfusion helps prevent short-term (post- randomization) and long-term (30 day) changes in delirium.

描述（由申请人提供）：拟议的一项辅助研究是针对接受髋部骨折修复手术的心血管患者的功能性结果的输血治疗试验（FOCUS），目的是在 200 名受试者的子样本中检查血红蛋白干预对谵妄的影响（每个随机分组 100 名）。 FOCUS 是一项由 NHLBI 资助的 2,000 名髋部骨折患者的随机临床试验，旨在检验较高的输血阈值不会改善功能恢复或降低发病率和死亡率的假设。患者被随机分配接受足够的血液以维持血红蛋白水平 >10 g/dL，而如果血红蛋白水平低于 8 g/dL 或出现贫血症状（对症策略），则接受输血。这项辅助研究将加深我们对输血阈值对谵妄影响的理解。主要目的是确定与 10 g/dL 输血策略相比，症状性输血策略 (8 g/dL) 是否与住院期间更严重的急性谵妄症状相关。次要目标将检查输血随机化是否也会影响出院后 30 天谵妄症状的持续性，并将检查住院期间谵妄症状持续性和 30 天持续性谵妄症状与以后功能结果的关系。这 200 名受试者将从 16 个 FOCUS 站点招募。 FOCUS受试者是髋部骨折患者，年龄50岁以上，有CVD或心血管危险因素病史，术后3天内血红蛋白水平低于10 g/dL。将在随机化前、随机化后最多 3 天（医院内）以及随机化后 30 天对受试者进行谵妄评估。结果包括 30 天和 60 天的发病率、死亡率、下肢功能、日常生活工具性活动和出院地点。我们的样本量预测旨在检测中等影响。广义估计方程将用于评估两组 100 名髋部骨折患者使用所有测量时间点的纵向模式。分析中将遵循意向治疗原则。分析将按随机分组进行，敏感性分析将检查各组之间的重要混杂因素是否存在差异及其对分析的影响。演出地点： 马里兰州巴尔的摩大学，马里兰州巴尔的摩 新泽西州新不伦瑞克市新泽西医学和牙科大学 贝斯以色列女执事医疗中心，哈佛医学院，马里兰州波士顿 巴尔的摩研究与教育基金会，马里兰州佩里角临床地点： 新泽西州新不伦瑞克省罗伯特伍德约翰逊医院 加拿大多伦多伦敦健康科学中心 加拿大多伦多梅奥诊所、​​圣玛丽医院，密歇根州罗彻斯特 桑尼布鲁克，加拿大多伦多约翰霍普金斯湾景医疗中心，巴尔的摩 MD 库珀大学医院，卡姆登，新泽西州 渥太华大学，渥太华，加拿大 东弗吉尼亚医学院，诺福克，弗吉尼亚州 哥伦比亚大学医学中心，纽约州纽约市 纽约长老会医院，纽约州纽约市 克利夫兰诊所，俄亥俄州克利夫兰，拉希诊所医疗中心，马萨诸塞州伯灵顿埃默里大学，佐治亚州亚特兰大德克萨斯技术大学，德克萨斯州拉伯克迈蒙德斯医疗中心，布鲁克林，加拿大温哥华不列颠哥伦比亚纽约大学这是一项大型临床试验 (R01 HL073958) 的一项辅助研究，该试验着眼于在患有心血管疾病或心血管风险的患者中使用不同水平的输血来治疗髋部骨折手术后失血因素。这项辅助研究检查输血是否有助于预防谵妄的短期（随机化后）和长期（30 天）变化。