- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027896
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
Intervention / Treatment
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.
Sponsor
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
- Borges FK, Devereaux PJ, Cuerden M, Bhandari M, Guerra-Farfan E, Patel A, Sigamani A, Umer M, Neary J, Tiboni M, Tandon V, Ramokgopa MT, Sancheti P, John B, Lawendy A, Balaguer-Castro M, Jenkinson R, Sleczka P, Nabi Nur A, Wood GCA, Feibel R, McMahon JS, Sigamani A, Biccard BM, Landoni G, Szczeklik W, Wang CY, Tomas-Hernandez J, Abraham V, Vincent J, Harvey V, Pettit S, Sontrop J, Garg AX; HIP ATTACK investigators. Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial. BMJ Open. 2019 Sep 24;9(9):e033150. doi: 10.1136/bmjopen-2019-033150.
- Borges FK, Bhandari M, Patel A, Avram V, Guerra-Farfan E, Sigamani A, Umer M, Tiboni M, Adili A, Neary J, Tandon V, Sancheti PK, Lawendy A, Jenkinson R, Ramokgopa M, Biccard BM, Szczeklik W, Wang CY, Landoni G, Forget P, Popova E, Wood G, Nabi Nur A, John B, Sleczka P, Feibel RJ, Balaguer-Castro M, Deheshi B, Winemaker M, de Beer J, Kolesar R, Teixidor-Serra J, Tomas-Hernandez J, McGillion M, Shanthanna H, Moppett I, Vincent J, Pettit S, Harvey V, Gauthier L, Alvarado K, Devereaux PJ. Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients. BMJ Open. 2019 May 1;9(4):e028537. doi: 10.1136/bmjopen-2018-028537.
- HIP ATTACK Investigators. Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial. Lancet. 2020 Feb 29;395(10225):698-708. doi: 10.1016/S0140-6736(20)30058-1. Epub 2020 Feb 9. Erratum In: Lancet. 2021 Nov 27;398(10315):1964. Lancet. 2023 Apr 1;401(10382):1078.
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
Keywords
Additional Relevant MeSH Terms
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
-
Khoo Teck Puat HospitalMinistry of Health, SingaporeActive, not recruitingHip Fracture Surgeries | Post-operative Hip Fractures RecoverySingapore
-
San Giovanni di Dio HospitalRecruitingHip Surgery | Hip ArthroplastyItaly
-
Smith & Nephew, Inc.Terminated
-
Medical Centre LeeuwardenNot yet recruitingHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)Netherlands
-
Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
-
Gaziantep City HospitalCompletedFemoral Neck Fractures | Hip SurgeryTurkey (Türkiye)
-
Carilion ClinicCompleted
-
Sheffield Teaching Hospitals NHS Foundation TrustRecruitingHip FractureUnited Kingdom
-
FH ORTHOTerminatedHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
Clinical Trials on Accelerated medical clearance and surgery
-
Population Health Research InstituteNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsRecruitingMyocardial Injury | Hip FracturesUnited States, Hong Kong, Spain, Canada, Pakistan, South Africa, Netherlands, Malaysia, Finland, Australia, Mexico, Nepal, Italy, Chile, India, Belgium, Brazil, Poland, Saudi Arabia
-
Johns Hopkins UniversityUniversity of Maryland, Baltimore; National Institute of Arthritis and Musculoskeletal... and other collaboratorsRecruitingOpen Tibia Fracture | Extremity Fracture Lower | Open Dislocation of Ankle | Extremity Injuries LowerUnited States, Australia, Spain
-
Karolinska InstitutetSt. Claraspital AGWithdrawnDiabetic Kidney DiseaseSweden, Switzerland
-
Istituto Auxologico ItalianoPolitecnico di MilanoRecruiting
-
University of British ColumbiaVancouver FoundationCompleted
-
University of Western Ontario, CanadaCanadian Institutes of Health Research (CIHR)CompletedOsteoarthritis of the KneeCanada
-
Centre d'Investigation Clinique et Technologique...TIMC-IMAG; Fondation pour la Recherche Médicale; Fondation GarchesUnknownOsteoarthritis | Joint Instability | Joint Disease | Bone MalalignmentFrance
-
Imperial College LondonRecruitingObesity | Type 2 DiabetesIreland
-
Southwest Hospital, ChinaRecruitingIntracerebral Hemorrhage Basal GangliaChina
-
NorthShore University HealthSystemTerminatedAsthma | Chronic SinusitisUnited States