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

• ClinicalTrials.gov Identifier: NCT04743765
• Recruitment Status: Recruiting
• First Posted: February 8, 2021
• Last Update Posted: December 15, 2021
• Sponsor: Population Health Research Institute
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): Population Health Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hip Fractures; Myocardial Injury	Other: Accelerated medical clearance and surgery	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 (HIP ATTACK-2) Trial
• Actual Study Start Date: November 22, 2021
• Estimated Primary Completion Date: April 15, 2025
• Estimated Study Completion Date: July 15, 2025

Arms and Interventions

Arm	Intervention/treatment
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.	Other: 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.
No Intervention: Standard surgical care; Hip fracture repair and surgical care according to treating institution guidelines.

Outcome Measures

Primary Outcome Measures :

1. All cause mortality [ Time Frame: Within 90 days post randomization ]
   Death due to all causes

Secondary Outcome Measures :

1. Ability to independently walk 3 meters [ Time Frame: Within 90 days post randomization ]
   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.
2. Composite of major complications [ Time Frame: Within 90 days post randomization ]
   Composite includes vascular and nonvascular mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke.
3. Vascular mortality [ Time Frame: Within 90 days post randomization ]
   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
4. Nonvascular mortality [ Time Frame: Within 90 days post randomization ]
   Any death due to a clearly documented non-vascular cause.
5. Myocardial Infarction [ Time Frame: Within 90 days post randomization ]
   Diagnosis of MI according to 4th universal definition of myocardial infarction
6. Acute Congestive Heart Failure [ Time Frame: Within 90 days post randomization ]

   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
   2. heart failure treatment implemented with diuretics with documented clinical improvement.
7. Stroke [ Time Frame: Within 90 days post randomization ]
   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
8. Time from randomization to hospital discharge [ Time Frame: Within 90 days post randomization ]
   Length of hospital stay from randomization to hospital discharge
9. Delirium [ Time Frame: Within 7 days and 90 days post randomization ]
   1. Patient meets the criteria for delirium on any in-person 3D-CAM administered; OR
   2. Positive history of delirium in the 7 days after randomization based on the review of hospital health records.
10. Moderate to severe pain [ Time Frame: Within 7 days and 90 days post randomization ]
    Moderate to severe pain is defined as any pain score ≥3 on 10 points scale.

Other Outcome Measures:

1. New clinically important atrial fibrillation [ Time Frame: Within 90 days post randomization ]
   Documentation of atrial fibrillation or atrial flutter of any duration on an ECG or rhythm strip and results in angina, congestive heart failure, symptomatic hypotension, or requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion.
2. Cardiac revascularization procedure [ Time Frame: Within 90 days post randomization ]
   Revascularization procedures including coronary artery bypass graft or percutaneous coronary intervention surgery.
3. Venous thromboembolism [ Time Frame: Within 90 days post randomization ]
   Venous pulmonary embolism or deep venous thrombosis
4. Pulmonary embolism [ Time Frame: Within 90 days post randomization ]

   The diagnosis of PE requires any one of the following:

   1. A high probability ventilation/perfusion lung scan,
   2. An intraluminal filling defect of a segmental or larger artery on a helical CT scan,
   3. An intraluminal filling defect on pulmonary angiography, or
   4. 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.

5. Proximal deep venous thrombosis [ Time Frame: Within 90 days post randomization ]

   The diagnosis of proximal DVT requires:

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

   1. 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.

6. Infection [ Time Frame: Within 90 days post randomization ]
   Pathologic process caused by the invasion of normally sterile tissue or fluid or body cavity by pathogenic or potentially pathogenic organisms.
7. Sepsis [ Time Frame: Within 90 days post randomization ]

   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 due to infection. The qSOFA includes the following items and scoring system:

   1. Altered mental status (1 point),
   2. Systolic blood pressure (SBP)of 100 mm Hg or less (1 point), and
   3. Respiratory rate (RR) of 22 breaths/min or more (1 point).
8. Pneumonia [ Time Frame: Within 90 days post randomization ]
   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.
9. Bleeding [ Time Frame: Within 90 days post randomization ]
   Life threatening, major or critical organ bleeding
10. Hip reoperation [ Time Frame: Within 90 days post randomization ]
    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.
11. Prosthetic hip dislocation [ Time Frame: Within 90 days post randomization ]
    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.
12. Implant failure [ Time Frame: Within 90 days post randomization ]
    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.
13. Peri-prosthetic fracture [ Time Frame: Within 90 days post randomization ]
    Fracture through any part of either the femur and/or acetabulum to which a hip implant used for hip repair/reconstruction was fixed.
14. Acute kidney injury [ Time Frame: Within 90 days post randomization ]
    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.
15. Acute renal failure resulting in dialysis [ Time Frame: Within 90 days post randomization ]
    New requirement for dialysis (i.e., use of hemodialysis machine or peritoneal dialysis apparatus in patients without a requirement for dialysis prior to surgery).
16. Hospital re-admission [ Time Frame: Within 90 days post randomization ]
    Hospital re-admission following discharge from index hospitalization
17. Length of critical care stay [ Time Frame: Within 90 days post randomization ]
    Length of critical care stay
18. Length of rehabilitation stay [ Time Frame: Within 90 days post randomization ]
    Length of rehabilitation stay
19. Days alive at home [ Time Frame: Within 90 days post randomization ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

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.

Contacts and Locations

Contacts

Contact: Valerie Harvey; 905-297-3479 ext 40793; valerie.harvey@phri.ca

Locations

Canada, Ontario

Juravinski Hospital; Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Contact: Krysten Gregus gregus@HHSC.ca

Principal Investigator: Ameen Patel, MD

Sponsors and Collaborators

Population Health Research Institute

Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Flavia Borges, M.D; Population Health Research Institute
• Principal Investigator: Gerard Slobogean, M.D; University of Maryland, College Park
• Principal Investigator: Robert Feibel, M.D; The Ottawa Hospital
• Study Chair: PJ Devereaux, M.D; Population Health Research Institute

More Information

• Responsible Party: Population Health Research Institute
• ClinicalTrials.gov Identifier: NCT04743765
• Other Study ID Numbers: v1.0_20210121
• First Posted: February 8, 2021
• Last Update Posted: December 15, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The Population Health Research Institute (PHRI) is the sponsor of this trial. The PHRI believes the dissemination of clinical research results is vital and sharing of data is important. PHRI prioritizes access to data analyses to researchers who have worked on the trial for a significant duration, have played substantial roles, and have participated in raising the funds to conduct the trial. PHRI balances the length of the research study, and the intellectual and financial investments that made it possible with the need to allow wider access to the data collected. Data will be disclosed only upon request and approval of the proposed use of the data by a Review Committee.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries