Health Trialsby

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

ConditionsHip Fractures Myocardial Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age45+

SponsorPopulation Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥45 years;

diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;

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

informed consent.

Disqualifiers

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;

patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);

patients with peri-prosthetic fracture, open fracture or bilateral fractures;

patients requiring an emergency surgery for another reason (e.g., subdural hematoma);

Trial design

Design model

Parallel

Treatments tested in this trial

Accelerated medical clearance and surgery
Other intervention
Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met.

Treatment groups

1,100 Participants

are divided into 2 treatment groups

Group A: Accelerated medical clearance and surgeryExperimental treatment 1 intervention

Group B: Standard surgical careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

All cause mortality

Death due to all causes

Time frame

Within 90 days post randomization

Secondary outcomes

1

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

2

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

3

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

4

Nonvascular mortality

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

Time frame

Within 90 days post randomization

Other outcomes

1

New clinically important atrial fibrillation or flutter

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.

Time frame

Within 90 days post randomization

2

Cardiac revascularization procedure

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

Time frame

Within 90 days post randomization

3

Venous thromboembolism

Venous pulmonary embolism or deep venous thrombosis

Time frame

Within 90 days post randomization

4

Pulmonary embolism

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.

Time frame

Within 90 days post randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Population Health Research Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov