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

Other authors

Institut Català de la Salut

[Borges FK] Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada. [Bhandari M, Avram V] Department of Surgery, McMaster University, Hamilton, Ontario, Canada. [Patel A] Department of Medicine, McMaster University, Hamilton, Ontario, Canada. [Guerra-Farfán E, Teixidor-Serra J, Tomas-Hernandez J] Servei de Cirurgia Ortopèdica i Traumatologia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. [Sigamani A] Department of Clinical Research, Narayana Health, Bangalore, India.

Vall d'Hebron Barcelona Hospital Campus

Publication date

2019-06-25T10:49:31Z

2019-06-25T10:49:31Z

2019-05-01

Abstract

Accelerated surgery; Hip fracture; Randomised control trial


Cirurgia accelerada; Fractura de maluc; Prova controlada aleatòria


Cirugía acelerada; Fractura de cadera; Prueba controlada aleatorizada


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.

Document Type

Article


Published version

Language

English

Publisher

BMJ Publishing Group

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BMJ Open;9(4)

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Attribution-NonCommercial-NoDerivatives 4.0 International

http://creativecommons.org/licenses/by-nc-nd/4.0/

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