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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,100
Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met.
Chandler Regional Medical Center
Chandler, Arizona, United States
ACTIVE_NOT_RECRUITINGThe Regents of the University of California
Davis, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California, Irvine
Irvine, California, United States
ACTIVE_NOT_RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
ACTIVE_NOT_RECRUITINGAll cause mortality
Death due to all causes
Time frame: Within 90 days post randomization
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.
Time frame: 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.
Time frame: 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
Time frame: Within 90 days post randomization
Nonvascular mortality
Any death due to a clearly documented non-vascular cause.
Time frame: Within 90 days post randomization
Myocardial Infarction
Diagnosis of MI according to 4th universal definition of myocardial infarction
Time frame: 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: 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.
Time frame: 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
Time frame: Within 90 days post randomization
Time from randomization to hospital discharge
Length of hospital stay from randomization to hospital discharge
Time frame: Within 90 days post randomization
Delirium
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.
Time frame: 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.
Time frame: Within 7 days and 90 days post randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Emory University at Grady Memorial Hospital
Atlanta, Georgia, United States
ACTIVE_NOT_RECRUITINGUniversity of Maryland
Baltimore, Maryland, United States
ACTIVE_NOT_RECRUITINGSinai Hospital of Baltimore
Baltimore, Maryland, United States
ACTIVE_NOT_RECRUITINGTufts Medical Center
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGLahey Hospital and Medical Center
Burlington, Massachusetts, United States
ACTIVE_NOT_RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
ACTIVE_NOT_RECRUITING...and 67 more locations