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.
Brief Title
HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
905-297-3479
Central Contact Phone Ext
40793
Central Contact Email
valerie.harvey@phri.ca
Completion Date
Completion Date Type
Estimated
Conditions
Hip Fractures
Myocardial Injury
Eligibility Criteria
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.
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.
Inclusion Criteria
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.
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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
45 Years
NCT Id
NCT04743765
Org Class
Other
Org Full Name
Population Health Research Institute
Org Study Id
v2.0_20230608
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 (HIP ATTACK-2) Trial
Primary Outcomes
Outcome Description
Death due to all causes
Outcome Measure
All cause mortality
Outcome Time Frame
Within 90 days post randomization
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Within 90 days post randomization
Outcome Measure
Ability to independently walk 3 meters
Outcome Description
Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke.
Outcome Time Frame
Within 90 days post randomization
Outcome Measure
Composite of major complications
Outcome Description
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
Outcome Time Frame
Within 90 days post randomization
Outcome Measure
Vascular mortality
Outcome Description
Any death due to a clearly documented non-vascular cause.
Outcome Time Frame
Within 90 days post randomization
Outcome Measure
Nonvascular mortality
Outcome Description
Diagnosis of MI according to 4th universal definition of myocardial infarction
Outcome Time Frame
Within 90 days post randomization
Outcome Measure
Myocardial Infarction
Outcome Description
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.
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.
Outcome Time Frame
Within 90 days post randomization
Outcome Measure
Acute Congestive Heart Failure
Outcome Description
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
Outcome Time Frame
Within 90 days post randomization
Outcome Measure
Stroke
Outcome Description
Length of hospital stay from randomization to hospital discharge
Outcome Time Frame
Within 90 days post randomization
Outcome Measure
Time from randomization to hospital discharge
Outcome Description
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.
2. Positive history of delirium in the 7 days after randomization based on the review of hospital health records.
Outcome Time Frame
Within 7 days and 90 days post randomization
Outcome Measure
Delirium
Outcome Description
Moderate to severe pain is defined as any pain score ≥3 on 10 points scale.
Outcome Time Frame
Within 7 days and 90 days post randomization
Outcome Measure
Moderate to severe pain
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
45
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lauren Crocco
Investigator Email
lcrocco@montefiore.org
Investigator Department
Orthopaedic Surgery
Investigator Sponsor Organization
External
Study Department
Orthopaedic Surgery
Study Division
Orthopedic Surgery
MeSH Terms
HIP FRACTURES
FEMORAL FRACTURES
FRACTURES, BONE
WOUNDS AND INJURIES
HIP INJURIES
LEG INJURIES
SURGICAL PROCEDURES, OPERATIVE