HIP Fracture Accelerated Surgical TreaTment and Care TracK 2 Trial
Purpose
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.
Conditions
- Hip Fractures
- Myocardial Injury
Eligibility
- Eligible Ages
- Over 45 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Accelerated medical clearance and surgery |
Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met. |
|
|
No Intervention Standard surgical care |
Hip fracture repair and surgical care according to treating institution guidelines. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Population Health Research Institute