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

Population Health Research Institute70 sites in 15 countries1,100 target enrollmentNovember 22, 2021

ConditionsHip Fractures Myocardial Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hip Fractures
Sponsor: Population Health Research Institute
Enrollment: 1100
Locations: 70
Primary Endpoint: All cause mortality
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 22, 2021

End Date

May 31, 2027

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Population Health Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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);
•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;
•patients refusing consent; or
•patients previously enrolled in HIP ATTACK-2.

Outcomes

Primary Outcomes

All cause mortality

Time Frame: Within 90 days post randomization

Death due to all causes

Secondary Outcomes

Delirium(Within 7 days and 90 days post randomization)
Myocardial Infarction(Within 90 days post randomization)
Ability to independently walk 3 meters(Within 90 days post randomization)
Composite of major complications(Within 90 days post randomization)
Vascular mortality(Within 90 days post randomization)
Stroke(Within 90 days post randomization)
Time from randomization to hospital discharge(Within 90 days post randomization)
Nonvascular mortality(Within 90 days post randomization)
Acute Congestive Heart Failure(Within 90 days post randomization)
Moderate to severe pain(Within 7 days and 90 days post randomization)