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

January 18, 2024 updated by: McMaster University
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 Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

3001

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium
        • Cliniques Universitaires Saint-luc
      • Woluwe-Saint-Lambert, Belgium
        • Cliniques Universitaires Saint-luc
    • Alberta
      • Calgary, Alberta, Canada
        • South Health Campus
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg,, Manitoba, Canada, MB R2K 2M9
        • Concordia Hip and Knee Institute
    • Nova Scotia
      • Halifax,, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences
    • Ontario
      • Barrie, Ontario, Canada
        • Royal Victoria Hospital
      • Etobicoke, Ontario, Canada
        • Etobicoke General Hospital
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Hospital Hamilton
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Health Sciences - Juravinski Hospital
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Kitchener, Ontario, Canada
        • Grand River Hospital
      • London, Ontario, Canada
        • Victoria Hospital, London Health Sciences
      • Markham, Ontario, Canada
        • Markham Stouffville Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa General Hospital
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Hospital
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
      • Beijing, China
        • Beijing ChaoYang Hospital
      • Bogotá, Colombia, 13B-60
        • Fundacion Cardioinfantil
      • Lyon, France
        • Centre Hospitalier Lyon Sud
      • Nîmes Cedex 09, France, 30029
        • Nîmes University Hospital
      • High West, Hong Kong
        • Queen Mary Hospital
      • Alappuzha, India, 688005
        • Government TD Medical College
      • Bangalore, India, 560099
        • Sparsh Hospital
      • Chandigarh, India
        • PGIMER
      • Hebbal, India, 560024
        • Bangalore Baptist Hospital
      • Kolkata, India, 700099
        • NH Kolkata
      • Ludhiana, India, 141008
        • CMC Ludhiana
      • Nagpur, India
        • Seven Star Hospital
      • New Delhi, India
        • AIIMS Hospital
      • Puducherry, India
        • JIPMER
      • Shivajinagar, India, 411005
        • Sancheti Institute for Orthopaedics and Rehabilitation
      • Trivandrum, India
        • Government Medical Hospital
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Milan, Italy
        • Humanitas Research Hospital
      • Milan, Italy
        • IRCCS Galeazzi Orthopedic Institute
      • Varese, Italy
        • ASST Sette Laghi - Ospedale Di
      • George Town, Malaysia
        • Hospital Pulau Pinang
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre (UMMC)
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Islāmābād, Pakistan, 44000
        • Shifa International Hospitals
      • Karachi, Pakistan, 74800
        • The Aga Khan University
      • Bochnia, Poland
        • SPZOZ Szpital Powiatowy w Bochni im M. Wieckiej
      • Myślenice, Poland, 32-400
        • Samodzielny Publiczny Zakład Opieki Zdrowotnej W Myślenicach
      • Łódź, Poland
        • University Hospital & Educational Center of Medical University in Lodz
      • Cape Town, South Africa
        • Stellenbosch University
      • Cape Town, South Africa, 7925
        • Groote Schuur Hospital
      • Johannesburg, South Africa, 2193
        • Chris Hani Baragwanath Hospital
      • Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • Barcelona, Spain, 08025
        • Hospital San Pau
      • Barcelona, Spain, 08035
        • Hospital Universitaire Vall d'Hebron
      • Barcelona, Spain, 08221
        • Mutua de Terrassa Hospital
      • Barcelona, Spain
        • Hospital Sant Camil (Consorci Sanitari Garraf)
      • Marbella, Spain, 29603
        • Costa del Sol
      • Valladolid, Spain
        • Hospital Clinico Universitario de Vallad
      • Bangkok,, Thailand, 10400
        • Ramathibodi Hospital
      • Huddersfield, United Kingdom
        • Calderdale & Huddersfield NHS
      • London, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital
      • London, United Kingdom
        • West Middlesex Hospital
      • Peterborough, United Kingdom
        • Peterborough City Hospital
      • Sutton in Ashfield, United Kingdom, NG17 4JL
        • King's Mill Hospital
    • California
      • San Jose, California, United States
        • Regional Medical Center of San Jose
    • Maryland
      • Baltimore, Maryland, United States, 20742
        • University of Maryland
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Centre
      • Washington, Massachusetts, United States, 02111
        • Tufts Medical Centre
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Surgical hip fracture repair according to the standard timing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
All-cause mortality
90 days
Composite - major perioperative complication
Time Frame: 90 days
Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 90 days
Length of hospital stay
90 days
All-cause mortality
Time Frame: 90 days and 1 year
Death due to all causes
90 days and 1 year
Vascular mortality
Time Frame: 90 days and 1 year
Death due to vascular cause
90 days and 1 year
Non-vascular mortality
Time Frame: 90 days and 1 year
Death due to non-vascular cause
90 days and 1 year
Myocardial infarction
Time Frame: 90 days and 1 year
Myocardial infarction
90 days and 1 year
Cardiac revascularization procedure
Time Frame: 90 days and 1 year
i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] surgery
90 days and 1 year
New congestive heart failure
Time Frame: 90 days and 1 year
New congestive heart failure
90 days and 1 year
New clinically important atrial fibrillation
Time Frame: 90 days
New clinically important atrial fibrillation
90 days
Nonfatal cardiac arrest
Time Frame: 30 days and 1 year
Nonfatal cardiac arrest
30 days and 1 year
Stroke
Time Frame: 90 days and 1 year
Stroke
90 days and 1 year
Peripheral arterial thrombosis
Time Frame: 90 days and 1 year
Peripheral arterial thrombosis
90 days and 1 year
Pulmonary embolism
Time Frame: 90 days and 1 year
Pulmonary embolism
90 days and 1 year
Deep venous thrombosis
Time Frame: 90 days and 1 year
Deep venous thrombosis
90 days and 1 year
Pneumonia
Time Frame: 90 days and 1 year
Pneumonia
90 days and 1 year
Sepsis
Time Frame: 90 days and 1 year
Sepsis
90 days and 1 year
Infection
Time Frame: 90 days
Infection
90 days
Life-threatening bleeding
Time Frame: 90 days
Life-threatening bleeding
90 days
Major bleeding
Time Frame: 90 days
Major bleeding
90 days
New acute renal failure requiring dialysis
Time Frame: 90 days and 1 year
New acute renal failure requiring dialysis
90 days and 1 year
Peri-prosthetic fracture
Time Frame: 90 days and 1 year
Peri-prosthetic fracture
90 days and 1 year
Prosthetic hip dislocation
Time Frame: 90 days and 1 year
Prosthetic hip dislocation
90 days and 1 year
Implant failure
Time Frame: 90 days and 1 year
Implant failure
90 days and 1 year
Hip re-operation
Time Frame: 30 days and 1 year
Hip re-operation
30 days and 1 year
Time to first mobilization
Time Frame: 90 days
Time to first mobilization
90 days
Length of critical care stay
Time Frame: 90 days
Length of critical care stay
90 days
Length of rehabilitation stay
Time Frame: 90 days
Length of rehabilitation stay
90 days
New residence in a nursing home
Time Frame: 90 days and 1 year
New residence in a nursing home
90 days and 1 year
Functional Independence Measure (FIM™)
Time Frame: 30 days and 1 year
Functional Independence Measure (FIM™)
30 days and 1 year
SF-36 score
Time Frame: 30 days and 1 year
SF-36 score
30 days and 1 year
Delirium within 7 days of randomization
Time Frame: 7 days
Delirium within 7 days of randomization
7 days
Hospital readmission
Time Frame: 90 days and 1 year
Hospital readmission
90 days and 1 year
New pressure ulcers
Time Frame: 90 days
New pressure ulcers
90 days
Incisional pain
Time Frame: 30 days
Incisional pain
30 days
Chronic incisional pain
Time Frame: 1 year
Chronic incisional pain
1 year
Acute Kidney Injury
Time Frame: 90 Day
Acute Kidney Injury
90 Day
Acute Kidney Injury
Time Frame: 1 Year
Acute Kidney Injury
1 Year
Mortality and Institutionalization status of dependents
Time Frame: 30 Days
Mortality and Institutionalization status of dependents
30 Days
Mortality and Institutionalization status of dependents
Time Frame: 1 Year
Mortality and Institutionalization status of dependents
1 Year
Economic Analysis
Time Frame: 90 Days and 1 Year
Economic Analysis
90 Days and 1 Year
Health System Utilization, Long Term Follow up
Time Frame: 2, 5, 10 Years
Health System Utilization, Long Term Follow up
2, 5, 10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Philip J Devereaux, MD, PhD, McMaster University
  • Principal Investigator: Mohit Bhandari, MD, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2014

Primary Completion (Actual)

August 24, 2019

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimated)

January 6, 2014

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HIP ATTACK Trial v5.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Fractures

Clinical Trials on Accelerated medical clearance and surgery

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