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

N/ACompletedNCT02027896

McMaster University3,001 enrolled

Overview

HIP ATTACK is an international randomized controlled trial of 3000 patients with a hip fracture that requires a surgical intervention. This trial will determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 90-day risk of mortality and major perioperative complication (i.e., a composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,001

Conditions

Hip Fractures

Interventions

Accelerated medical clearance and surgeryOTHER

Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age ≥45 years; and * diagnosis of hip fracture during working hours with a low-energy mechanism (i.e., falling from standing height) requiring surgery. Exclusion Criteria: * patients requiring emergent surgery or emergent interventions for another reason (e.g., subdural hematoma, abdominal pathology requiring urgent laparotomy, acute limb ischemia, other fractures or trauma requiring emergent surgery, necrotising fasciitis, coronary revascularization, pacemaker-implantation); * open hip fracture; * bilateral hip fractures; * peri-prosthetic fracture; * therapeutic anticoagulation not induced by a Vitamin K Antagonist, unfractionated heparin, (e.g., administration of therapeutic Low Molecular Weight Heparin (LMWH) (\>6,000 u/24h) in the 24 hours prior to enrolment, or intake of any other non-reversible oral anticoagulant(s) for which there is no reversing agent available * patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT); * patients refusing participation; or * patients previously enrolled in the study.

Locations (69)

Outcomes

Primary Outcomes

Composite - major perioperative complication

Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding

Time frame: 90 days

Mortality

All-cause mortality

Time frame: 90 days

Secondary Outcomes

All-cause mortality

Death due to all causes

Time frame: 90 days and 1 year

Vascular mortality

Death due to vascular cause

Time frame: 90 days and 1 year

Non-vascular mortality

Death due to non-vascular cause

Time frame: 90 days and 1 year

Myocardial infarction

Time frame: 90 days and 1 year

Cardiac revascularization procedure

i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\] surgery

Time frame: 90 days and 1 year

New congestive heart failure

Time frame: 90 days and 1 year

New clinically important atrial fibrillation

Data from ClinicalTrials.gov

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Regional Medical Center of San Jose

San Jose, California, United States

University of Maryland

Baltimore, Maryland, United States

Lahey Hospital and Medical Centre

Burlington, Massachusetts, United States

Tufts Medical Centre

Washington, Massachusetts, United States

Ohio State University Medical Centre

Columbus, Ohio, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

South Health Campus

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

...and 59 more locations

Nonfatal cardiac arrest

Time frame: 30 days and 1 year

Stroke

Time frame: 90 days and 1 year

Peripheral arterial thrombosis

Time frame: 90 days and 1 year

Pulmonary embolism

Time frame: 90 days and 1 year

Deep venous thrombosis

Time frame: 90 days and 1 year

Pneumonia

Time frame: 90 days and 1 year

Sepsis

Time frame: 90 days and 1 year

Infection

Time frame: 90 days

Life-threatening bleeding

Time frame: 90 days

Major bleeding

Time frame: 90 days

New acute renal failure requiring dialysis

Time frame: 90 days and 1 year

Peri-prosthetic fracture

Time frame: 90 days and 1 year

Prosthetic hip dislocation

Time frame: 90 days and 1 year

Implant failure

Time frame: 90 days and 1 year

Hip re-operation

Time frame: 30 days and 1 year

Time to first mobilization

Time frame: 90 days

Length of hospital stay

Time frame: 90 days

Length of critical care stay

Time frame: 90 days

Length of rehabilitation stay

Time frame: 90 days

New residence in a nursing home

Time frame: 90 days and 1 year

Functional Independence Measure (FIM™)

Time frame: 30 days and 1 year

SF-36 score

Time frame: 30 days and 1 year

Delirium within 7 days of randomization

Time frame: 7 days

Hospital readmission

Time frame: 90 days and 1 year

New pressure ulcers

Time frame: 90 days

Incisional pain

Time frame: 30 days

Chronic incisional pain

Time frame: 1 year

Acute Kidney Injury

Time frame: 90 Day

Acute Kidney Injury

Time frame: 1 Year

Mortality and Institutionalization status of dependents

Time frame: 30 Days

Mortality and Institutionalization status of dependents

Time frame: 1 Year

Economic Analysis

Time frame: 90 Days and 1 Year

Health System Utilization, Long Term Follow up

Time frame: 2, 5, 10 Years