跳至主要内容
临床试验/CTRI/2022/08/045084
CTRI/2022/08/045084尚未招募不适用

HIP fracture Accelerated surgical TreaTment And Care tracK 2 Trial

Population Health Research Institute6 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2022年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,100
试验地点
6
主要终点
All-cause mortality - Death due to all causes

研究概览

简要总结

Patients suffering a hip fracture with an acute myocardial injury are at substantial risk for mortality. The current standard of care is to delay surgery for those patients while additional tests and potential treatments are implemented with the intention of minimizing the risk of post-operative complications. However, there is no RCT data demonstrating that cardiac stabilization and surgical delay are beneficial for these patients. Among the patients with an acute myocardial injury randomized to standard care in the HIP ATTACK-1 trial mortality was more than doubled as compared to patients that underwent accelerated surgery.

There exists a strong biological rationale for how accelerated surgical treatment of a hip fracture and an acute myocardial injury may lower a patient’s risk of death. There is also encouraging data from HIP ATTACK-1 trial suggesting that early surgery for a hip fracture reduces a patient’s risk of mortality. Moreover, the HIP ATTACK-1 trial demonstrated the feasibility of a trial comparing accelerated medical assessment and surgery versus standard care in those patients. Currently, most patients wait more than 24 hours to have surgery after diagnosis of a hip fracture when there is an ongoing myocardial injury. The need for a large adequately powered trial to settle the issue in a clear way that will drive subsequent practice is compelling.

This is the first large trial that may change the paradigm to postpone surgery in patients suffering acute myocardial injuries before surgery, proposing a novel approach to reverse myocardial injury through expedited surgical care.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
45.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • age ≥45 years; 2) diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery; 3) troponin elevation on hospital arrival (at least one troponin level from hip fracture occurrence to randomization above the upper limit of normal); and 4) written informed consent.

排除标准

  • taking a therapeutic dose of an anticoagulant for which no reversing agent is available; 2) patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT); 3) patients with peri-prosthetic fracture, open fracture or bilateral fractures; 4) patients requiring an emergency surgery for another reason (e.g., subdural hematoma); 5) patients with acute myocardial infarction with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect), ST elevation myocardial infarction, or cardiogenic shock; 6) patients refusing consent; or 7) patients previously enrolled in HIP ATTACK-2.

结局指标

主要结局

All-cause mortality - Death due to all causes

时间窗: 90 days after randomization

次要结局

  • 1.Ability to independently walk 3 meters(2.Composite of major complications)

研究者

申办方类型
Research institution

研究点 (6)

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