HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial (HIP ATTACK-2)

Population Health Research Institute (PHRI)

Status: Enrolling

Conditions: Hip Fractures; Myocardial Injury

Treatments: Other: Accelerated medical clearance and surgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04743765

v2.0_20230608

Details and patient eligibility

About

The HIP ATTACK-2 trial is a 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. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

Enrollment: 1,100 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age ≥45 years;
2. diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;
3. troponin elevation ( at least one troponin measurement above the upper limit of normal occurring from the time of hip fracture to the time of randomization); and
4. informed consent.

Exclusion criteria

1. taking a therapeutic dose of an anticoagulant for which no reversing agent is available and the anesthesiologist or surgeon believe surgery within 6 hours of eligibility criteria met would not be safe;
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 deemed to be clinically unstable, 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,100 participants in 2 patient groups

Accelerated medical clearance and surgery

Experimental group

Description:

Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met.

Treatment:

Other: Accelerated medical clearance and surgery

Standard surgical care

No Intervention group

Description:

Hip fracture repair and surgical care according to treating institution guidelines.