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

IntroductionAnnually, 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...

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Published in	BMJ open Vol. 9; no. 4; p. e028537
Main Authors	Borges, Flavia K, Bhandari, Mohit, Patel, Ameen, Avram, Victoria, Guerra-Farfán, Ernesto, Sigamani, Alben, Umer, Masood, Tiboni, Maria, Adili, Anthony, Neary, John, Tandon, Vikas, Sancheti, Parag K, Lawendy, AbdelRahman, Jenkinson, Richard, Ramokgopa, Mmampapatla, Biccard, Bruce M, Szczeklik, Wojciech, Wang, Chew Yin, Landoni, Giovanni, Forget, Patrice, Popova, Ekaterine, Wood, Gavin, Nabi Nur, Aamer, John, Bobby, Ślęczka, Paweł, Feibel, Robert J, Balaguer-Castro, Mariano, Deheshi, Benjamin, Winemaker, Mitchell, de Beer, Justin, Kolesar, Richard, Teixidor-Serra, Jordi, Tomas-Hernandez, Jordi, McGillion, Michael, Shanthanna, Harsha, Moppett, Iain, Vincent, Jessica, Pettit, Shirley, Harvey, Valerie, Gauthier, Leslie, Alvarado, Kim, Devereaux, P J
Format	Journal Article
Language	English
Published	England BMJ Publishing Group LTD 01.05.2019 BMJ Publishing Group
Subjects	Aged Clinical trials Evidence-based medicine Female Fractures Health care delivery Health risk assessment Hip Fractures - mortality Hip Fractures - surgery Hip joint Humans Joint surgery Male Middle Aged Mortality Postoperative Complications - epidemiology Research Design Surgery Time Factors hip fracture accelerated surgery randomised control trial
Online Access	Get full text
ISSN	2044-6055 2044-6055
DOI	10.1136/bmjopen-2018-028537

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Abstract	IntroductionAnnually, 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 analysisHIP 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 disseminationAll 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.
AbstractList	IntroductionAnnually, 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 analysisHIP 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 disseminationAll 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. 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. 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. 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. NCT02027896; Pre-results. IntroductionAnnually, 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 analysisHIP 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 disseminationAll 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 numberNCT02027896; Pre-results. 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.INTRODUCTIONAnnually, 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.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.METHODS AND ANALYSISHIP 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.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.ETHICS AND DISSEMINATIONAll 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.NCT02027896; Pre-results.TRIAL REGISTRATION NUMBERNCT02027896; Pre-results.
Author	Borges, Flavia K Lawendy, AbdelRahman Patel, Ameen Moppett, Iain Umer, Masood Vincent, Jessica Pettit, Shirley Forget, Patrice Winemaker, Mitchell de Beer, Justin Ramokgopa, Mmampapatla Szczeklik, Wojciech Wang, Chew Yin Deheshi, Benjamin Feibel, Robert J Jenkinson, Richard Avram, Victoria Ślęczka, Paweł Adili, Anthony Tandon, Vikas Alvarado, Kim Sigamani, Alben Sancheti, Parag K Balaguer-Castro, Mariano John, Bobby McGillion, Michael Tomas-Hernandez, Jordi Popova, Ekaterine Landoni, Giovanni Guerra-Farfán, Ernesto Bhandari, Mohit Teixidor-Serra, Jordi Wood, Gavin Harvey, Valerie Shanthanna, Harsha Neary, John Biccard, Bruce M Gauthier, Leslie Nabi Nur, Aamer Devereaux, P J Tiboni, Maria Kolesar, Richard
AuthorAffiliation	13 Department of Anaesthesia and Perioperative Medicine , University of Cape Town , Cape Town , South Africa 1 Department of Perioperative Medicine , Population Health Research Institute , Hamilton , Ontario , Canada 17 Department of Anaesthesia and Intensive Care , IRCCS San Raffaele Scientific Institute , Milan , Italy 3 Department of Medicine , McMaster University , Hamilton , Ontario , Canada 7 Department of Orthopaedic Surgery , Sancheti Institute for Orthopaedics & Rehabilitation , Pune , India 31 Departments of Health Research Methods, Evidence, and Impact (HEI) , McMaster University , Hamilton , Canada 30 Hamilton Health Sciences , Hamilton , Ontario , Canada 11 Department of Orthopaedic Surgery , Chris Hani Baragwanath Academic Hospital , Johannesburg , South Africa 4 Department of Orthopaedic Surgery and Traumatology , Vall d’Hebron University Hospital , Barcelona , Spain 19 Biomedical Research Institute (IIB – SANT PAU) , Barcelona , Spain 21 Shifa International Hospital , Islamabad ,
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surname: Tandon fullname: Tandon, Vikas email: philipj@mcmaster.ca organization: Department of Medicine, McMaster University, Hamilton, Ontario, Canada – sequence: 12 givenname: Parag K surname: Sancheti fullname: Sancheti, Parag K email: philipj@mcmaster.ca organization: Department of Orthopaedic Surgery, Sancheti Institute for Orthopaedics & Rehabilitation, Pune, India – sequence: 13 givenname: AbdelRahman surname: Lawendy fullname: Lawendy, AbdelRahman email: philipj@mcmaster.ca organization: Department of Surgery, London Health Sciences Centre, London, Ontario, Canada – sequence: 14 givenname: Richard surname: Jenkinson fullname: Jenkinson, Richard email: philipj@mcmaster.ca organization: Department of Surgery and Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada – sequence: 15 givenname: Mmampapatla surname: Ramokgopa fullname: Ramokgopa, Mmampapatla email: philipj@mcmaster.ca organization: University of the Witwatersrand, 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philipj@mcmaster.ca organization: Department of Surgery, McMaster University, Hamilton, Ontario, Canada – sequence: 31 givenname: Richard surname: Kolesar fullname: Kolesar, Richard email: philipj@mcmaster.ca organization: Department of Anaesthesia, McMaster University, Hamilton, Ontario, Canada – sequence: 32 givenname: Jordi surname: Teixidor-Serra fullname: Teixidor-Serra, Jordi email: philipj@mcmaster.ca organization: Department of Orthopaedic Surgery and Traumatology, Vall d’Hebron University Hospital, Barcelona, Spain – sequence: 33 givenname: Jordi surname: Tomas-Hernandez fullname: Tomas-Hernandez, Jordi email: philipj@mcmaster.ca organization: Department of Orthopaedic Surgery and Traumatology, Vall d’Hebron University Hospital, Barcelona, Spain – sequence: 34 givenname: Michael surname: McGillion fullname: McGillion, Michael email: philipj@mcmaster.ca organization: School of Nursing, McMaster University, Hamilton, Canada – sequence: 35 givenname: Harsha surname: Shanthanna fullname: Shanthanna, Harsha email: philipj@mcmaster.ca organization: Department of Anaesthesia, McMaster University, Hamilton, Ontario, Canada – sequence: 36 givenname: Iain surname: Moppett fullname: Moppett, Iain email: philipj@mcmaster.ca organization: Department of Anaesthesia & Critical Care, University of Nottingham, Nottingham, UK – sequence: 37 givenname: Jessica surname: Vincent fullname: Vincent, Jessica email: philipj@mcmaster.ca organization: Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada – sequence: 38 givenname: Shirley surname: Pettit fullname: Pettit, Shirley email: philipj@mcmaster.ca organization: Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada – sequence: 39 givenname: Valerie surname: Harvey fullname: Harvey, Valerie email: philipj@mcmaster.ca organization: Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada – sequence: 40 givenname: Leslie surname: Gauthier fullname: Gauthier, Leslie email: philipj@mcmaster.ca organization: Hamilton Health Sciences, Hamilton, Ontario, Canada – sequence: 41 givenname: Kim surname: Alvarado fullname: Alvarado, Kim email: philipj@mcmaster.ca organization: School of Nursing, McMaster University, Hamilton, Canada – sequence: 42 givenname: P J surname: Devereaux fullname: Devereaux, P J email: philipj@mcmaster.ca organization: Departments of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, Canada
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Copyright_xml	– notice: Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. – notice: 2019 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2019
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DOI	10.1136/bmjopen-2018-028537
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Keywords	hip fracture accelerated surgery randomised control trial
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Snippet	IntroductionAnnually, 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.... 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... IntroductionAnnually, 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....
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StartPage	e028537
SubjectTerms	Aged Clinical trials Evidence-based medicine Female Fractures Health care delivery Health risk assessment Hip Fractures - mortality Hip Fractures - surgery Hip joint Humans Joint surgery Male Middle Aged Mortality Postoperative Complications - epidemiology Research Design Surgery Time Factors
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Title	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
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