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: 7837527
• 负责人: ANN L GRUBER-BALDINI
• 金额: $ 26.48万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7837527
• 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）：提议是针对接受手术髋关节骨折修复（FOCUS）的心血管疾病患者的输血疗法试验的辅助研究，以检查血红蛋白干预对200受试者的妄想的影响（100个随机分组）。 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，旨在检验较高输血阈值不能改善功能恢复或降低发病率和死亡率的假设。如果血红蛋白水平小于8 g/dl，或者当贫血症状出现时，患者被随机接受足够的血液以保持血红蛋白水平> 10 g/dL与接受输血相比（症状策略）。这项辅助研究将扩展我们的理解输血阈值对del妄的影响。主要目的是确定与10 g/dl输血策略相比，住院期间有症状的输血策略（8 g/dl）是否与更严重的急性del妄症状有关。次要目的将检查输血随机化是否还会影响入院后30天时del妄症状的持续性，并将检查医院的关联以及del妄症状在以后的功能结果上的30天持久性。 200名受试者将从16个焦点站点招募。重点受试者是50岁以上的髋部骨折患者，具有CVD或心血管危险因素的病史，并且在手术后3天内具有术后血红蛋白水平小于10 g/dL的患者。将评估受试者在随机前的ir妄前分组，最多3天（院内），并在随机后30天评估。结果包括30天和60天的发病率，死亡率，下肢功能，日常生活的工具活动以及出院位置。我们的样本量预测试图检测中等效果。通用估计方程将使用所有测量时间点评估两组100个髋部骨折患者之间的纵向模式。分析将遵循治疗原则的意图。分析将由随机组进行，灵敏度分析将检查组之间重要的混杂因素及其对分析的影响是否存在差异。绩效网站：马里兰州巴尔的摩大学，巴尔的摩，医学博士医学院和新泽西大学牙科，新不伦瑞克省，新泽西医院，罗切斯特，密歇根州多伦多，加拿大多伦多，约翰·霍普金斯·贝维尤医学中心，巴尔的摩库珀大学医院，卡姆登，卡姆登，新泽西州奥托瓦大学，加拿大奥托瓦大学，加拿大伊托瓦瓦，东部弗吉尼亚州东部医学院，弗吉尼亚州诺福克，弗吉尼亚州哥伦比亚哥伦比亚大学医学中心，纽约，伯灵顿，马萨诸塞州伯灵顿，佐治亚州亚特兰大，德克萨斯州亚特兰大技术，德克萨斯州拉伯克，马蒙德医学中心，布鲁克林，布鲁克林，纽约州不列颠哥伦比亚大学，加拿大温哥华，这是一项对大型临床试验的辅助研究（R01 HL073958），该研究（r01 HL073958）都查看了治疗血液损失的患者，这些疾病又是在治疗后遭受血液损失的水平风险因素。这项辅助研究检查了输血是否有助于预防短期（随机后）和长期（30天）的ir妄变化。