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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

Borges FK 1 , Bhandari M 2 , Patel A 3 , Avram V 2 , Guerra-Farfán E 4 , Sigamani A 5 Show all authors , Umer M 6 , Tiboni M 3 , Adili A 2 , Neary J 3 , Tandon V 3 , Sancheti PK 7 , Lawendy A 8 , Jenkinson R 9 , Ramokgopa M 10 , Biccard BM 11 , Szczeklik W 12 , Wang CY 13 , Landoni G 14 , Forget P 15 , Popova E 16 , Wood G 17 , Nabi Nur A 18 , John B 19 , Ślęczka P 20 , Feibel RJ 21 , Balaguer-Castro M 22 , Deheshi B 23 , Winemaker M 2 , de Beer J 2 , Kolesar R 24 , Teixidor-Serra J 4 , Tomas-Hernandez J 4 , McGillion M 25 , Shanthanna H 24 , Moppett I 26 , Vincent J 1 , Pettit S 1 , Harvey V 1 , Gauthier L 27 , Alvarado K 25 , Devereaux PJ 1

Affiliations 

  • 1 Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada
  • 2 Department of Surgery, McMaster University, Hamilton, Ontario, Canada
  • 3 Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  • 4 Department of Orthopaedic Surgery and Traumatology, Vall d'Hebron University Hospital, Barcelona, Spain
  • 5 Department of Clinical Research, Narayana Health, Bangalore, India
  • 6 Department of Orthopaedic Surgery, Aga Khan University, Karachi, Pakistan
  • 7 Department of Orthopaedic Surgery, Sancheti Institute for Orthopaedics & Rehabilitation, Pune, India
  • 8 Department of Surgery, London Health Sciences Centre, London, Ontario, Canada
  • 9 Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  • 10 Department of Orthopaedic Surgery, Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa
  • 11 Department of Anaesthesia and Perioperative Medicine, University of Cape Town, Cape Town, South Africa
  • 12 Department of Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Kraków, Poland
  • 13 Department of Anaesthesiology, University of Malaya, Kuala Lumpur, Malaysia
  • 14 Vita-Salute San Raffaele University, Milano, Italy
  • 15 Department of Anesthesiology and Perioperative Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium
  • 16 Biomedical Research Institute (IIB - SANT PAU), Barcelona, Spain
  • 17 Department of Surgery, Queen's University, Kingston, Ontario, Canada
  • 18 Shifa International Hospital, Islamabad, Pakistan
  • 19 Department of Orthopaedic Surgery, Christian Medical College, Ludhiana, India
  • 20 Orthopaedics, SPZOZ, Myslenice, Poland
  • 21 Department of Surgery, University of Ottawa, Ottawa, Ontario, Canada
  • 22 Department of Orthopaedic Surgery and Traumatology, Parc Taulí Hospital Universitari, Barcelona, Spain
  • 23 Department of Orthopaedics, Sharif Surgical Oncology, Fort Worth, Texas, USA
  • 24 Department of Anaesthesia, McMaster University, Hamilton, Ontario, Canada
  • 25 School of Nursing, McMaster University, Hamilton, Canada
  • 26 Department of Anaesthesia & Critical Care, University of Nottingham, Nottingham, UK
  • 27 Hamilton Health Sciences, Hamilton, Ontario, Canada
BMJ Open, 2019 05 01;9(4):e028537.
PMID: 31048449 DOI: 10.1136/bmjopen-2018-028537

Abstract

INTRODUCTION: Annually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%-10% at 30 days and 10%-20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial-HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.

METHODS AND ANALYSIS: HIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.

ETHICS AND DISSEMINATION: All centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.

TRIAL REGISTRATION NUMBER: NCT02027896; Pre-results.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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