HIP fracture Accelerated surgical TreaTment And Care tracK-2 (HIP ATTACK-2) trial

HIP 骨折加速手术治疗和护理 track-2 (HIP ATTACK-2) 试验

• 批准号: 10673739
• 负责人: Flavia Kessler Borges
• 金额: $ 98.21万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10673739
• 关键词: Acceleration; Acute; Adrenergic Agents; American; Biological Markers; Caring; Clinical Pathways; Confidence Intervals; Delirium; Diagnosis; Early Mobilizations; Eligibility Determination; Enrollment; Ensure; Etiology; Exposure to; Fracture; Funding; Goals; Health; Healthcare Systems; Heart Injuries; Hemorrhage; Hip Fractures; Hospitals; Hour; Inflammation; Injury; International; Medical; National Institute of Arthritis, and Musculoskeletal, and Skin Diseases; Nature; Operative Surgical Procedures; Orthopedics; Outcome; Pain; Participant; Patient Care; Patient-Focused Outcomes; Patients; Physiological; Population; Populations at Risk; Preoperative Care; Quality of life; Randomized; Randomized, Controlled Trials; Reporting; Research; Risk; Risk Reduction; Sample Size; Serum; Site; Stress; Subgroup; Surgical complication; Testing; Time; Troponin; United States; Urinary tract infection; bone; experience; foot; hazard; improved; improved outcome; independent ambulation; medical complication; mortality; mortality risk; novel; patient prognosis; prevent; response; standard care; standard of care; study population; trial comparing

ABSTRACT The proposed trial, HIP ATTACK-2, seeks to improve the outcomes of thousands of patients who present to the hospital with a hip fracture and concomitant acute heart injury. Acute heart injury is characterized by an elevated serum troponin; this heart injury is often asymptomatic but can be identified in up to 20% of hip fracture patients prior to surgery. These patients have a much worse prognosis than patients with no heart injury (i.e., 24% versus 8% 90-day mortality, respectively). Despite the magnitude of this problem, standard medical management has made little progress in improving the outcomes of these patients. The objective of the HIP ATTACK-2 trial is to confirm the previous post-hoc subgroup findings by comparing accelerated surgery (<6 hours) to standard care in hip fracture patients presenting with elevated serum troponin. This multicenter, parallel group randomized controlled trial will address three specific aims: 1) to determine if accelerated surgery reduces the risk of 90-day mortality in hip fracture patients who also have an acute heart injury, 2) to determine if accelerated surgery increases the proportion of patients able to independently ambulate 10 feet at 90-days, 3) to determine if accelerated surgery improves patient-reported quality of life and decreases medical and surgical complications.

摘要 拟议中的试验，HIP ATTACK-2，旨在改善数千名患者的结果， 因髋部骨折和伴随急性心脏损伤住院。急性心脏损伤的特征是 血清肌钙蛋白;这种心脏损伤通常无症状，但可在高达20%的髋部骨折患者中发现 在手术前。这些患者的预后比没有心脏损伤的患者差得多（即，24%， 8%的90天死亡率）。尽管这个问题的严重性，标准的医疗管理， 在改善这些患者的预后方面进展甚微。HIP ATTACK-2试验的目的是 通过比较加速手术（<6小时）与标准治疗，确认先前的事后亚组结果 髋部骨折患者血清肌钙蛋白升高。该多中心、平行组随机 对照试验将解决三个具体目标：1）确定加速手术是否会降低90天的风险 同时伴有急性心脏损伤的髋部骨折患者的死亡率，2）确定加速手术是否 增加了90天时能够独立行走10英尺的患者比例，3）确定是否 加速手术改善了患者报告的生活质量，并减少了医疗和手术并发症。