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
| Autor: | Benjamin Deheshi, Gavin C A Wood, Aamer Nabi Nur, Maria Tiboni, Leslie Gauthier, Ekaterine Popova, Masood Umer, Patrice Forget, Parag Sancheti, Flávia Kessler Borges, Alben Sigamani, Philip J. Devereaux, Iain K. Moppett, Mitchell Winemaker, Wojciech Szczeklik, Mohit Bhandari, Abdel-Rahman Lawendy, Richard Kolesar, Vikas Tandon, Mariano Balaguer-Castro, Paweł Ślęczka, Shirley Pettit, Jordi Teixidor-Serra, Victoria Avram, Michael McGillion, Giovanni Landoni, Valerie Harvey, Ernesto Guerra-Farfán, Chew Yin Wang, Bobby John, Jordi Tomas-Hernandez, Ameen Patel, Anthony Adili, John Neary, Robert J. Feibel, Justin de Beer, Mmampapatla Thomas Ramokgopa, Richard Jenkinson, Bruce M Biccard, Jessica Vincent, Kim Alvarado, Harsha Shanthanna |
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| Přispěvatelé: | 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, Supporting clinical sciences, Anesthesiology, Borges, Flavia K, Bhandari, Mohit, Patel, Ameen, Avram, Victoria, Guerra-Farfán, Ernesto, Sigamani, Alben, Umer, Masood, Tiboni, Maria, Adili, Anthony, Neary, John, Tandon, Vika, 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 |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
Time Factors accelerated surgery law.invention 0302 clinical medicine Postoperative Complications Randomized controlled trial law Informed consent Protocol 030212 general & internal medicine Stroke Medicine(all) Hip fracture Mortality rate Wounds and Injuries::Fractures Bone::Femoral Fractures::Hip Fractures [DISEASES] General Medicine Middle Aged Other subheadings::Other subheadings::/surgery [Other subheadings] 3. Good health Pulmonary embolism Research Design hip fracture randomised control trial Female medicine.medical_specialty heridas y lesiones::fracturas óseas::fracturas del fémur::fracturas de cadera [ENFERMEDADES] 03 medical and health sciences Health Care Facilities Manpower and Services::Health Services::Preventive Health Services::Early Medical Intervention [HEALTH CARE] medicine Health Care Quality Access and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics::Clinical Protocols::Clinical Trial Protocols as Topic [HEALTH CARE] Humans Articulació coxofemoral - Cirurgia Aged business.industry Hip Fractures Otros calificadores::Otros calificadores::/cirugía [Otros calificadores] Perioperative medicine.disease calidad acceso y evaluación de la atención sanitaria::calidad de la atención sanitaria::mecanismos de evaluación de la atención sanitaria::características de los estudios epidemiológicos::protocolos clínicos::protocolos de ensayos clínicos como asunto [ATENCIÓN DE SALUD] Physical therapy instalaciones servicios y personal de asistencia sanitaria::servicios de salud::servicios preventivos de salud::intervención médica temprana [ATENCIÓN DE SALUD] Observational study Surgery business 030217 neurology & neurosurgery Assaigs clínics |
| Zdroj: | BMJ Open r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname Scientia |
| ISSN: | 2044-6055 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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