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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的拟议的试验HIP Attack-2试图改善成千上万的患者的结果患有髋部骨折和伴有急性心脏损伤的医院。急性心脏损伤的特征是升高血清肌钙蛋白；这种心脏损伤通常是无症状的，但可以在多达20％的髋部骨折患者中识别手术前。这些患者的预后比没有心脏损伤的患者要差得多（即24％与分别为8％90天死亡率）。尽管有这个问题的幅度，但标准医疗管理已有在改善这些患者的结果方面几乎没有取得进展。 HIP Attack-2试验的目的是通过将加速手术（<6小时）与标准护理进行比较，确认先前的事后亚组发现结果在髋部骨折患者中，血清肌钙蛋白升高。这个多中心，并联随机对照试验将解决三个具体目标：1）确定加速手术是否降低了90天的风险髋部骨折患者的死亡率也患有急性心脏损伤，2）确定是否加速手术增加能够在90天时独立行动10英尺的患者的比例，3）确定是否是否加速手术可改善患者报告的生活质量，并降低医疗和手术并发症。