Multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization

Not yet recruiting

Conditions: Physeal fracture of upper end of femur,

Registration Number: CTRI/2022/08/045084

Lead Sponsor: Population Health Research Institute

Brief Summary: 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 patientâ€™s risk of death. There is also encouraging data from HIP ATTACK-1 trial suggesting that early surgery for a hip fracture reduces a patientâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 1100

Inclusion Criteria

age â‰¥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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality - Death due to all causes	90 days after randomization

Secondary Outcome Measures

Name	Time	Method
1.Ability to independently walk 3 meters	2.Composite of major complications

Trial Locations

Locations (6): All India Institute of Medical License
🇮🇳
Delhi, DELHI, India
Bangalore Baptist Hospital
🇮🇳
Bangalore, KARNATAKA, India
Government Medical College
🇮🇳
Thiruvananthapuram, KERALA, India
Government TD Medical College
🇮🇳
Alappuzha, KERALA, India
Jawaharlal Institute of Postgraduate Medical Education & Research
🇮🇳
Pondicherry, PONDICHERRY, India
Sancheti Institute of Orthopedics and Rehabilitation
🇮🇳
Pune, MAHARASHTRA, India
All India Institute of Medical License
🇮🇳Delhi, DELHI, India
Dr Vijay Sharma
Principal investigator
9899502492
drvijaysharmatrauma@gmail.com