HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Fractures, Myocardial Injury

Intervention / Treatment
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* Other: Accelerated medical clearance and surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥45 years; diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery; troponin elevation on hospital arrival (at least one troponin level from hip fracture occurrence to randomization above the upper limit of normal); and written informed consent. Exclusion Criteria: taking a therapeutic dose of an anticoagulant for which no reversing agent is available; patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT); patients with peri-prosthetic fracture, open fracture or bilateral fractures; patients requiring an emergency surgery for another reason (e.g., subdural hematoma); 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; patients refusing consent; or patients previously enrolled in HIP ATTACK-2.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accelerated medical clearance and surgery<br>Accelerated medical clearance and targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair. | Other: Accelerated medical clearance and surgery<br>* Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.<br>|
| No Intervention: Standard surgical care<br>Hip fracture repair and surgical care according to treating institution guidelines. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Death due to all causes | Within 90 days post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to independently walk 3 meters | 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. | Within 90 days post randomization | 
| Composite of major complications | Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke. | Within 90 days post randomization | 
| Vascular mortality | 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 | Within 90 days post randomization | 
| Nonvascular mortality | Any death due to a clearly documented non-vascular cause. | Within 90 days post randomization | 
| Myocardial Infarction | Diagnosis of MI according to 4th universal definition of myocardial infarction | Within 90 days post randomization | 
| Acute Congestive Heart Failure | 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: radiographic findings (i.e., vascular redistribution, interstitial pulmonary edema, or frank alveolar pulmonary edema) OR heart failure treatment implemented with diuretics with documented clinical improvement. | Within 90 days post randomization | 
| Stroke | 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 | Within 90 days post randomization | 
| Time from randomization to hospital discharge | Length of hospital stay from randomization to hospital discharge | Within 90 days post randomization | 
| Delirium | Patient meets the criteria for delirium on any in-person 3D-CAM administered; OR Positive history of delirium in the 7 days after randomization based on the review of hospital health records. | Within 7 days and 90 days post randomization | 
| Moderate to severe pain | Moderate to severe pain is defined as any pain score ≥3 on 10 points scale. | Within 7 days and 90 days post randomization |