HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

Death due to all causes

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 includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke.

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

Any death due to a clearly documented non-vascular cause.

Diagnosis of MI according to 4th universal definition of myocardial infarction

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 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
• heart failure treatment implemented with diuretics with documented clinical improvement.

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

Length of hospital stay from randomization to hospital discharge

• Patient meets the criteria for delirium on any in-person 3D-CAM or CAM administered; OR
• Positive history of delirium in the 7 days after randomization based on the review of hospital health records.

Moderate to severe pain is defined as any pain score ≥3 on 10 points scale.

Documentation of atrial fibrillation or atrial flutter of any duration on an ECG, telemetry tracing, or rhythm strip and results in angina, congestive heart failure, symptomatic hypotension, or is followed by initiation or a dose increase of a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.

Revascularization procedures including coronary artery bypass graft or percutaneous coronary intervention surgery.

Venous pulmonary embolism or deep venous thrombosis

The diagnosis of PE requires any one of the following:

• A high probability ventilation/perfusion lung scan,
• An intraluminal filling defect of a segmental or larger artery on a helical CT scan,
• An intraluminal filling defect on pulmonary angiography, or
• A positive diagnostic test for DVT (e.g., positive compression ultrasound) and one of the following:

A. Non-diagnostic (i.e., low or intermediate probability) ventilation/perfusion lung scan B. Non-diagnostic (i.e., subsegmental defects or technically inadequate study) helical CT scan.

The diagnosis of proximal DVT requires:

• Thrombosis involving the popliteal vein or more proximal veins for leg DVT and axillary or more proximal veins for arm DVT, AND
• Evidence of vein thrombosis by any one of the following:

• A persistent intraluminal filling defect on contrast venography, 2. Noncompressibility of one or more venous segments on B mode compression ultrasonography, or 3. A clearly defined intraluminal filling defect on contrast enhanced computed tomography.

Pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.

Based on the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria,20 sepsis will require a quick Sequential Organ Failure Assessment (qSOFA) Score ≥2 points or patients requiring vasopressors/inotropes due to infection. The qSOFA includes the following items and scoring system:

• Altered mental status (1 point),
• Systolic blood pressure (SBP)of 100 mm Hg or less (1 point), and
• Respiratory rate (RR) of 22 breaths/min or more (1 point).

Acute infection of the pulmonary parenchyma that is associated with at least one sign or symptom of lower respiratory acute infection (e.g., cough, pleuritic chest pain) or acute systemic illness (e.g., fever, chills, confusion, hypoxemia); accompanied by the presence of an acute infiltrate/consolidation on a chest radiograph or auscultatory findings consistent with pneumonia (such as crackles and/or localized rales) for which there is no other explanation.

Life threatening, major or critical organ bleeding

Any second surgical procedure undertaken on the fractured hip being followed in the study, for any reason (e.g. infection, implant failure, periprosthetic fracture, wound dehiscence, etc.), after it has been initially repaired and the patient has left the operating room.

Any acute dislocation of a prosthetic femoral head from within its intended concentric location within the acetabulum. The acetabulum may or may not be resurfaced/replaced.

Any mechanical issue related to the integrity of any component of the hip implant which requires a surgical procedure to correct. This includes: loss of implant fixation to bone (either with or without associated periprosthetic fracture); or broken, disassociated, or dislocated implant components.

Fracture through any part of either the femur and/or acetabulum to which a hip implant used for hip repair/reconstruction was fixed.

An increase in the serum creatinine concentration from the pre-randomization value of ≥26.5 μmol/L (≥0.3 mg/dL) within 48 hours after randomization, or an increase of ≥50% within 7 days after randomization.

New requirement for dialysis (i.e., use of hemodialysis machine or peritoneal dialysis apparatus in patients without a requirement for dialysis prior to randomization).

Hospital re-admission following discharge from index hospitalization

Length of critical care stay

Length of rehabilitation stay

Days alive at home are the number of days patients spend at their usual residence without, during that day, being admitted to a hospital or visiting an emergency department or urgent-care centre. Patients lose days alive at home if 1. patients go to an emergency department or urgent-care centre; 2. they become inpatients at a hospital or rehabilitation or convalescence-care facility; or 3. they die.