Clinical trial NCT04743765: HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial
Official title: HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 (HIP ATTACK-2) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Myocardial Injury
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-02-08
Enrollment: 1100
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: The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.


Eligibility criteria: Inclusion Criteria:

1. age ≥45 years;
2. diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;
3. troponin elevation ( at least one troponin measurement above the upper limit of normal occurring from the time of hip fracture to the time of randomization); and
4. informed consent.

Exclusion Criteria:

1. taking a therapeutic dose of an anticoagulant for which no reversing agent is available and the anesthesiologist or surgeon believe surgery within 6 hours of eligibility criteria met would not be safe;
2. patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);
3. patients with peri-prosthetic fracture, open fracture or bilateral fractures;
4. patients requiring an emergency surgery for another reason (e.g., subdural hematoma);
5. patients with acute myocardial infarction deemed to be clinically unstable, with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect), ST elevation myocardial infarction, or cardiogenic shock;
6. patients refusing consent; or
7. patients previously enrolled in HIP ATTACK-2.

Primary outcomes:
measure: All cause mortality
timeFrame: Within 90 days post randomization
Secondary outcomes:
measure: Ability to independently walk 3 meters
timeFrame: Within 90 days post randomization
measure: Composite of major complications
timeFrame: Within 90 days post randomization
measure: Vascular mortality
timeFrame: Within 90 days post randomization
measure: Nonvascular mortality
timeFrame: Within 90 days post randomization
measure: Myocardial Infarction
timeFrame: Within 90 days post randomization
measure: Acute Congestive Heart Failure
timeFrame: Within 90 days post randomization
measure: Stroke
timeFrame: Within 90 days post randomization
measure: Time from randomization to hospital discharge
timeFrame: Within 90 days post randomization
measure: Delirium
timeFrame: Within 7 days and 90 days post randomization
measure: Moderate to severe pain
timeFrame: Within 7 days and 90 days post randomization
Other outcomes:
measure: New clinically important atrial fibrillation or flutter
timeFrame: Within 90 days post randomization
measure: Cardiac revascularization procedure
timeFrame: Within 90 days post randomization
measure: Venous thromboembolism
timeFrame: Within 90 days post randomization
measure: Pulmonary embolism
timeFrame: Within 90 days post randomization
measure: Proximal deep venous thrombosis
timeFrame: Within 90 days post randomization
measure: Infection
timeFrame: Within 90 days post randomization
measure: Sepsis
timeFrame: Within 90 days post randomization
measure: Pneumonia
timeFrame: Within 90 days post randomization
measure: Bleeding
timeFrame: Within 90 days post randomization
measure: Hip reoperation
timeFrame: Within 90 days post randomization
measure: Prosthetic hip dislocation
timeFrame: Within 90 days post randomization
measure: Implant failure
timeFrame: Within 90 days post randomization
measure: Peri-prosthetic fracture
timeFrame: Within 90 days post randomization
measure: Acute kidney injury
timeFrame: Within 90 days post randomization
measure: Acute renal failure resulting in dialysis
timeFrame: Within 90 days post randomization
measure: Hospital re-admission
timeFrame: Within 90 days post randomization
measure: Length of critical care stay
timeFrame: Within 90 days post randomization
measure: Length of rehabilitation stay
timeFrame: Within 90 days post randomization
measure: Days alive at home
timeFrame: Within 90 days post randomization
Locations:
city: Davis
country: United States
facility: The Regents of the University of California
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lincoln
country: United States
facility: Bryan Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: New Lambton Heights
country: Australia
facility: The John Hunter Hospital
state: New South Wales
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint Luc - University Catholic of Louvain
state: Brussels
city: São Paulo
country: Brazil
facility: University of São Paulo
state: SP
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
city: Markham
country: Canada
facility: Markham Stouffville Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Laval
country: Canada
facility: CISSS de Laval
state: Quebec
city: Santiago
country: Chile
facility: Pontifica Universidad Catolica de Chile
state: RM
city: Santiago
country: Chile
facility: Clinica Santa Maria
city: Lappeenranta
country: Finland
facility: South Karelia Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
state: Delhi
city: Bangalore
country: India
facility: Bangalore Baptist Hospital
state: Karnataka
city: Alappuzha
country: India
facility: Government TD Medical College
state: Kerala
city: Trivandrum
country: India
facility: Government Medical College
state: Kerala
city: Pondicherry
country: India
facility: JIPMER
city: Perugia
country: Italy
facility: Hospital of Perugia
state: Umbria
city: Genova
country: Italy
facility: Galliera Hospital
city: Milan
country: Italy
facility: Ospedale San Raffaele S.r.l.
city: Milan
country: Italy
facility: Ospedale Galeazzi SpA
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Guadalajara
country: Mexico
facility: Cruz Verde Guadalajara
state: Jalisco
city: Chihuahua
country: Mexico
facility: Christus Muguerza del Parque
city: Lalitpur
country: Nepal
facility: B and B Hospital
state: Bagmati
city: Deventer
country: Netherlands
facility: Deventer Hospital
state: Overijssel
city: Amsterdam
country: Netherlands
facility: Stichting OLVG
city: Islamabad
country: Pakistan
facility: Maroof International Hospital
state: ICT
city: Islamabad
country: Pakistan
facility: Shifa International Hospitals Ltd.
state: ICT
city: Peshawar
country: Pakistan
facility: Hayat Abad Medical Complex
state: KPK
city: Lahore
country: Pakistan
facility: Ghurki Trust Teaching Hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Combined Military Hospital
state: Punjab
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
city: Karachi
country: Pakistan
facility: Indus Hospital & Health Network
state: Sind
city: Myslenice
country: Poland
facility: SPZOZ Myslenice
state: Malopolska
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital
city: Cape Town
country: South Africa
facility: Stellenbosch University - Tygerberg Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona
city: Sant Pere De Ribes
country: Spain
facility: Hospital Sant Camil
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitario Mutua de Terrassa
state: Barcelona
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Malaga
city: Barcelona
country: Spain
facility: Hospital Universitari Sagrat Cor
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Parc Sanitari Sant Joan de Déu
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Vallad
Study officials:
affiliation: Population Health Research Institute
name: Flavia Borges, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Gerard Slobogean, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital
name: Robert Feibel, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Population Health Research Institute
name: PJ Devereaux, M.D
role: STUDY_CHAIR
References: