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Recruiting NCT04743765

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

No phase Interventional Hip Fractures Myocardial Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Accelerated medical clearance and surgery.
Who it may be relevant to
Registry conditions: Hip Fractures, Myocardial Injury. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Brazil, Canada +14
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 (HIP ATTACK-2) Trial

Overview

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.

Interventions

  • Other Accelerated medical clearance and surgery
    Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met.

Primary outcome measures

  • All cause mortality [Time frame: Within 90 days post randomization]
Secondary outcome measures (10)
  • Ability to independently walk 3 meters [Time frame: Within 90 days post randomization]
  • Composite of major complications [Time frame: Within 90 days post randomization]
  • Vascular mortality [Time frame: Within 90 days post randomization]
  • Nonvascular mortality [Time frame: Within 90 days post randomization]
  • Myocardial Infarction [Time frame: Within 90 days post randomization]
  • Acute Congestive Heart Failure [Time frame: Within 90 days post randomization]
  • Stroke [Time frame: Within 90 days post randomization]
  • Time from randomization to hospital discharge [Time frame: Within 90 days post randomization]
  • Delirium [Time frame: Within 7 days and 90 days post randomization]
  • Moderate to severe pain [Time frame: Within 7 days and 90 days post randomization]

Eligibility criteria

Inclusion criteria

  • age ≥45 years;
  • diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;
  • 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
  • informed consent.

Exclusion criteria

  • 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;
  • patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);
  • patients with peri-prosthetic fracture, open fracture or bilateral fractures;
  • patients requiring an emergency surgery for another reason (e.g., subdural hematoma);
  • 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;
  • patients refusing consent; or
  • patients previously enrolled in HIP ATTACK-2.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 19 centers
  • Chandler Regional Medical Center — Chandler
  • The Regents of the University of California — Davis
  • Yale New Haven Hospital — New Haven
  • Emory University at Grady Memorial Hospital — Atlanta
  • University of Maryland — Baltimore
  • Sinai Hospital of Baltimore — Baltimore
  • Tufts Medical Center — Boston
  • Lahey Hospital and Medical Center — Burlington
  • … and 11 more centers
Spain · 10 centers
  • Hospital Universitari Sagrat Cor — Barcelona
  • Hospital Universitari Vall d'Hebron — Barcelona
  • Hospital Clinic of Barcelona — Barcelona
  • Hospital de la Santa Creu I Sant Pau — Barcelona
  • Hospital Universitari Parc Tauli — Sabadell
  • Hospital Sant Camil — Sant Pere de Ribes
  • Hospital Universitario Mutua de Terrassa — Terrassa
  • Hospital Costa del Sol — Marbella
  • … and 2 more centers
Canada · 7 centers
  • University of Alberta Hospital — Edmonton
  • St. Joseph's Healthcare Hamilton — Hamilton
  • Juravinski Hospital — Hamilton
  • Victoria Hospital — London
  • Markham Stouffville Hospital — Markham
  • Ottawa General Hospital — Ottawa
  • CISSS de Laval — Laval
Pakistan · 7 centers
  • Maroof International Hospital — Islamabad
  • Shifa International Hospitals Ltd. — Islamabad
  • Hayat Abad Medical Complex — Peshawar
  • Ghurki Trust Teaching Hospital — Lahore
  • Combined Military Hospital — Rawalpindi
  • Aga Khan University — Karachi
  • Indus Hospital & Health Network — Karachi
India · 5 centers
  • Bangalore Baptist Hospital — Bangalore
  • Government TD Medical College — Alappuzha
  • Government Medical College — Trivandrum
  • All India Institute of Medical Sciences (AIIMS) — New Delhi
  • JIPMER — Puducherry
Italy · 4 centers
  • Hospital of Perugia — Perugia
  • Galliera Hospital — Genova
  • Ospedale San Raffaele S.r.l. — Milan
  • Ospedale Galeazzi SpA — Milan
Chile · 2 centers
  • Pontifica Universidad Catolica de Chile — Santiago
  • Clinica Santa Maria — Santiago
Finland · 2 centers
  • South Karelia Central Hospital — Lappeenranta
  • Tampere University Hospital — Tampere
Mexico · 2 centers
  • Christus Muguerza del Parque — Chihuahua City
  • Cruz Verde Guadalajara — Guadalajara
Netherlands · 2 centers
  • Deventer Hospital — Deventer
  • Stichting OLVG — Amsterdam
South Africa · 2 centers
  • Stellenbosch University - Tygerberg Hospital — Cape Town
  • Groote Schuur Hospital — Cape Town
Australia · 1 center
  • The John Hunter Hospital — New Lambton Heights
Belgium · 1 center
  • Cliniques Universitaires Saint Luc - University Catholic of Louvain — Woluwe-Saint-Lambert
Brazil · 1 center
  • University of São Paulo — São Paulo
Hong Kong · 1 center
  • Queen Mary Hospital — Hong Kong
Malaysia · 1 center
  • University of Malaya Medical Centre — Kuala Lumpur
Nepal · 1 center
  • B and B Hospital — Lalitpur
Poland · 1 center
  • SPZOZ Myslenice — Myślenice
Saudi Arabia · 1 center
  • King Faisal Specialist Hospital — Riyadh

Identifiers

NCT: NCT04743765 · v2.0_20230608

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗