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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04743765
Registration number
NCT04743765
Ethics application status
Date submitted
3/02/2021
Date registered
8/02/2021
Date last updated
22/05/2024
Titles & IDs
Public title
HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial
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Scientific title
HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 (HIP ATTACK-2) Trial
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Secondary ID [1]
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v1.0_20210121
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Universal Trial Number (UTN)
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Trial acronym
HIP ATTACK-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip Fractures
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Myocardial Injury
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Accelerated medical clearance and surgery
Experimental: Accelerated medical clearance and surgery - Accelerated medical clearance and targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.
No Intervention: Standard surgical care - Hip fracture repair and surgical care according to treating institution guidelines.
Other interventions: Accelerated medical clearance and surgery
Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All cause mortality
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Assessment method [1]
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Death due to all causes
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Timepoint [1]
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Within 90 days post randomization
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Secondary outcome [1]
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Ability to independently walk 3 meters
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Assessment method [1]
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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.
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Timepoint [1]
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Within 90 days post randomization
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Secondary outcome [2]
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Composite of major complications
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Assessment method [2]
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Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke.
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Timepoint [2]
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Within 90 days post randomization
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Secondary outcome [3]
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Vascular mortality
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Assessment method [3]
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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
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Timepoint [3]
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Within 90 days post randomization
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Secondary outcome [4]
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Nonvascular mortality
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Assessment method [4]
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Any death due to a clearly documented non-vascular cause.
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Timepoint [4]
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Within 90 days post randomization
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Secondary outcome [5]
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Myocardial Infarction
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Assessment method [5]
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Diagnosis of MI according to 4th universal definition of myocardial infarction
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Timepoint [5]
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Within 90 days post randomization
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Secondary outcome [6]
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Acute Congestive Heart Failure
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Assessment method [6]
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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.
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Timepoint [6]
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Within 90 days post randomization
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Secondary outcome [7]
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Stroke
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Assessment method [7]
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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
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Timepoint [7]
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Within 90 days post randomization
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Secondary outcome [8]
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Time from randomization to hospital discharge
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Assessment method [8]
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Length of hospital stay from randomization to hospital discharge
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Timepoint [8]
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Within 90 days post randomization
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Secondary outcome [9]
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Delirium
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Assessment method [9]
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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.
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Timepoint [9]
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Within 7 days and 90 days post randomization
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Secondary outcome [10]
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Moderate to severe pain
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Assessment method [10]
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Moderate to severe pain is defined as any pain score =3 on 10 points scale.
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Timepoint [10]
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Within 7 days and 90 days post randomization
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Eligibility
Key inclusion criteria
1. age =45 years;
2. diagnosis of hip fracture during working hours with a low-energy mechanism requiring
surgery;
3. troponin elevation on hospital arrival (at least one troponin level from hip fracture
occurrence to randomization above the upper limit of normal); and
4. written informed consent.
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. taking a therapeutic dose of an anticoagulant for which no reversing agent is
available;
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 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/07/2025
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Actual
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Sample size
Target
1100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The John Hunter Hospital - New Lambton Heights
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Recruitment postcode(s) [1]
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2305 - New Lambton Heights
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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Michigan
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Country [4]
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United States of America
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State/province [4]
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Nebraska
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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Belgium
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State/province [6]
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Brussels
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Brazil
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SP
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Country [8]
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Canada
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State/province [8]
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Alberta
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Country [9]
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Canada
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State/province [9]
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Ontario
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Chile
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State/province [10]
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RM
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Chile
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State/province [11]
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Santiago
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Country [12]
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Finland
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State/province [12]
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Lappeenranta
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Finland
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State/province [13]
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Tampere
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Hong Kong
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State/province [14]
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Hong Kong
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Country [15]
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India
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State/province [15]
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Karnataka
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Country [16]
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India
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State/province [16]
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Kerala
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Italy
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State/province [17]
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Milan
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Malaysia
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State/province [18]
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Kuala Lumpur
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Mexico
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Jalisco
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Mexico
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State/province [20]
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Chihuahua
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Nepal
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State/province [21]
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Bagmati
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Netherlands
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Overijssel
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Pakistan
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ICT
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Pakistan
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KPK
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Pakistan
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Punjab
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Pakistan
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Sindh
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Pakistan
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Sind
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Poland
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Malopolska
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Saudi Arabia
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Riyadh
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South Africa
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State/province [30]
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Western Cape
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Country [31]
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Spain
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State/province [31]
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Barcelona
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Country [32]
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Spain
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State/province [32]
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Malaga
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Country [33]
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Spain
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State/province [33]
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Valladolid
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Funding & Sponsors
Primary sponsor type
Other
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Name
Population Health Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04743765
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Flavia Borges, M.D
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Address
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Population Health Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Valerie Harvey
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Address
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Country
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Phone
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905-297-3479
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04743765
Download to PDF