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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3001

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires Saint-luc
      • Woluwe-Saint-Lambert, Belgium
        • Cliniques Universitaires Saint-luc
  • Canada
    • 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
  • China
      • Beijing, China
        • Beijing ChaoYang Hospital
  • Colombia
      • Bogotá, Colombia, 13B-60
        • Fundacion Cardioinfantil
  • France
      • Lyon, France
        • Centre Hospitalier Lyon Sud
      • Nîmes Cedex 09, France, 30029
        • Nîmes University Hospital
  • Hong Kong
      • High West, Hong Kong
        • Queen Mary Hospital
  • India
      • 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
  • Italy
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Milan, Italy
        • Humanitas Research Hospital
      • Milan, Italy
        • IRCCS Galeazzi Orthopedic Institute
      • Varese, Italy
        • ASST Sette Laghi - Ospedale Di
  • Malaysia
      • George Town, Malaysia
        • Hospital Pulau Pinang
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre (UMMC)
  • Netherlands
      • Deventer, Netherlands
        • Deventer Ziekenhuis
  • Pakistan
      • Islāmābād, Pakistan, 44000
        • Shifa International Hospitals
      • Karachi, Pakistan, 74800
        • The Aga Khan University
  • Poland
      • 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
  • South Africa
      • Cape Town, South Africa
        • Stellenbosch University
      • Cape Town, South Africa, 7925
        • Groote Schuur Hospital
      • Johannesburg, South Africa, 2193
        • Chris Hani Baragwanath Hospital
  • Spain
      • 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
  • Thailand
      • Bangkok,, Thailand, 10400
        • Ramathibodi Hospital
  • United Kingdom
      • 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
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
Surgical hip fracture repair according to the standard timing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hamilton Health Sciences Corporation
Population Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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