Hip Fractures, Myocardial Injury
Conditions
Brief summary
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.
Interventions
Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met.
Sponsors
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | Within 90 days post randomization | Death due to all causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to independently walk 3 meters | Within 90 days post randomization | Ability to independently walk 3 meters (10 feet) or across a room without human assistance. Patients who require a cane or walker, but not human assistance, will be classified as able to walk independently. Patients who require assistance to get out of a chair, but can walk independently once they get up, will be classified as able to walk independently. |
| Composite of major complications | Within 90 days post randomization | Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke. |
| Vascular mortality | Within 90 days post randomization | Any death with a vascular cause and includes those deaths following a myocardial infarction, sudden cardiac arrest, stroke, cardiac revascularization procedure (i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery), heart failure, pulmonary embolus, cardiovascular hemorrhage, or deaths due to an unknown cause |
| Nonvascular mortality | Within 90 days post randomization | Any death due to a clearly documented non-vascular cause. |
| Myocardial Infarction | Within 90 days post randomization | Diagnosis of MI according to 4th universal definition of myocardial infarction |
| Acute Congestive Heart Failure | Within 90 days post randomization | at least one clinical sign(s) or symptom(s) (e.g elevated jugular venous pressure, respiratory rales/crackles, crepitations, hypoxia, tachypnea or presence of S3) with at least one of the following: 1. radiographic findings (i.e., vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) or point of care ultrasound findings (i.e., bilateral B-lines, bilateral pleural effusion, elevated jugular venous pressure, dilated inferior vena cava with respiratory variation less than 50%) OR 2. heart failure treatment implemented with diuretics with documented clinical improvement. |
| Stroke | Within 90 days post randomization | Either - 1. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting more than 24 hours or leading to death; or 2. a new focal neurological deficit thought to be vascular in origin with signs or symptoms lasting less 24 hours with a positive neuroimaging consistent with a stroke |
| Time from randomization to hospital discharge | Within 90 days post randomization | Length of hospital stay from randomization to hospital discharge |
| Moderate to severe pain | Within 7 days and 90 days post randomization | Moderate to severe pain is defined as any pain score ≥3 on 10 points scale. |
| Delirium | Within 7 days and 90 days post randomization | 1. Patient meets the criteria for delirium on any in-person 3D-CAM or CAM administered; OR 2. Positive history of delirium in the 7 days after randomization based on the review of hospital health records. |
Countries
Australia, Belgium, Brazil, Canada, Chile, Finland, Hong Kong, India, Italy, Malaysia, Mexico, Nepal, Netherlands, Pakistan, Poland, Saudi Arabia, South Africa, Spain, United Kingdom, United States
Contacts
CONTACTValerie Harvey
PRINCIPAL_INVESTIGATORFlavia Borges, M.D
Population Health Research Institute
PRINCIPAL_INVESTIGATORGerard Slobogean, M.D
UC Irvine
PRINCIPAL_INVESTIGATORRobert Feibel, M.D
The Ottawa Hospital
STUDY_CHAIRPJ Devereaux, M.D
Population Health Research Institute
Outcome results
None listed