Clinical trial NCT02027896: HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial
Official title: HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Perioperative outcomes
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Population Health Research Institute
name: Hamilton Health Sciences Corporation
First posted: 2014-01-06
Enrollment: 3001
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Composite - major perioperative complication
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 90 days and 1 year
measure: Vascular mortality
timeFrame: 90 days and 1 year
measure: Non-vascular mortality
timeFrame: 90 days and 1 year
measure: Myocardial infarction
timeFrame: 90 days and 1 year
measure: Cardiac revascularization procedure
timeFrame: 90 days and 1 year
measure: New congestive heart failure
timeFrame: 90 days and 1 year
measure: New clinically important atrial fibrillation
timeFrame: 90 days
measure: Nonfatal cardiac arrest
timeFrame: 30 days and 1 year
measure: Stroke
timeFrame: 90 days and 1 year
measure: Peripheral arterial thrombosis
timeFrame: 90 days and 1 year
measure: Pulmonary embolism
timeFrame: 90 days and 1 year
measure: Deep venous thrombosis
timeFrame: 90 days and 1 year
measure: Pneumonia
timeFrame: 90 days and 1 year
measure: Sepsis
timeFrame: 90 days and 1 year
measure: Infection
timeFrame: 90 days
measure: Life-threatening bleeding
timeFrame: 90 days
measure: Major bleeding
timeFrame: 90 days
measure: New acute renal failure requiring dialysis
timeFrame: 90 days and 1 year
measure: Peri-prosthetic fracture
timeFrame: 90 days and 1 year
measure: Prosthetic hip dislocation
timeFrame: 90 days and 1 year
measure: Implant failure
timeFrame: 90 days and 1 year
measure: Hip re-operation
timeFrame: 30 days and 1 year
measure: Time to first mobilization
timeFrame: 90 days
measure: Length of hospital stay
timeFrame: 90 days
measure: Length of critical care stay
timeFrame: 90 days
measure: Length of rehabilitation stay
timeFrame: 90 days
measure: New residence in a nursing home
timeFrame: 90 days and 1 year
measure: Functional Independence Measure (FIM™)
timeFrame: 30 days and 1 year
measure: SF-36 score
timeFrame: 30 days and 1 year
measure: Delirium within 7 days of randomization
timeFrame: 7 days
measure: Hospital readmission
timeFrame: 90 days and 1 year
measure: New pressure ulcers
timeFrame: 90 days
measure: Incisional pain
timeFrame: 30 days
measure: Chronic incisional pain
timeFrame: 1 year
measure: Acute Kidney Injury
timeFrame: 90 Day
measure: Acute Kidney Injury
timeFrame: 1 Year
measure: Mortality and Institutionalization status of dependents
timeFrame: 30 Days
measure: Mortality and Institutionalization status of dependents
timeFrame: 1 Year
measure: Economic Analysis
timeFrame: 90 Days and 1 Year
measure: Health System Utilization, Long Term Follow up
timeFrame: 2, 5, 10 Years
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Regional Medical Center of San Jose
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital and Medical Centre
state: Massachusetts
city: Washington
country: United States
facility: Tufts Medical Centre
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University Medical Centre
state: Ohio
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg,
country: Canada
facility: Concordia Hip and Knee Institute
state: Manitoba
city: Halifax,
country: Canada
facility: QEII Health Sciences
state: Nova Scotia
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Etobicoke
country: Canada
facility: Etobicoke General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: London
country: Canada
facility: Victoria Hospital, London Health Sciences
state: Ontario
city: Markham
country: Canada
facility: Markham Stouffville Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Bogotá
country: Colombia
facility: Fundacion Cardioinfantil
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Nîmes Cedex 09
country: France
facility: Nimes University Hospital
city: High West
country: Hong Kong
facility: Queen Mary Hospital
city: Alappuzha
country: India
facility: Government TD Medical College
city: Bangalore
country: India
facility: Sparsh Hospital
city: Chandigarh
country: India
facility: PGIMER
city: Hebbal
country: India
facility: Bangalore Baptist Hospital
city: Kolkata
country: India
facility: NH Kolkata
city: Ludhiana
country: India
facility: CMC Ludhiana
city: Nagpur
country: India
facility: Seven Star Hospital
city: New Delhi
country: India
facility: AIIMS Hospital
city: Puducherry
country: India
facility: JIPMER
city: Shivajinagar
country: India
facility: Sancheti Institute for Orthopaedics and Rehabilitation
city: Trivandrum
country: India
facility: Government Medical Hospital
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Milan
country: Italy
facility: Humanitas Research Hospital
city: Milan
country: Italy
facility: IRCCS Galeazzi Orthopedic Institute
city: Varese
country: Italy
facility: ASST Sette Laghi - Ospedale Di
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre (UMMC)
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Islāmābād
country: Pakistan
facility: Shifa International Hospitals
city: Karachi
country: Pakistan
facility: The Aga Khan University
city: Bochnia
country: Poland
facility: SPZOZ Szpital Powiatowy w Bochni im M. Wieckiej
city: Myślenice
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej W Myślenicach
city: Łódź
country: Poland
facility: University Hospital & Educational Center of Medical University in Lodz
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Cape Town
country: South Africa
facility: Stellenbosch University
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hospital
city: Barcelona
country: Spain
facility: Hospital San Pau
city: Barcelona
country: Spain
facility: Hospital Universitaire Vall d'Hebron
city: Barcelona
country: Spain
facility: Corporació Sanitària Parc Taulí
city: Barcelona
country: Spain
facility: Mutua de Terrassa Hospital
city: Barcelona
country: Spain
facility: Hospital Sant Camil (Consorci Sanitari Garraf)
city: Marbella
country: Spain
facility: Costa del Sol
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Vallad
city: Bangkok,
country: Thailand
facility: Ramathibodi Hospital
city: Huddersfield
country: United Kingdom
facility: Calderdale & Huddersfield NHS
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: West Middlesex Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
city: Sutton in Ashfield
country: United Kingdom
facility: King's Mill Hospital
Study officials:
affiliation: McMaster University
name: Philip J Devereaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Mohit Bhandari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.