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

Hip Fractures Clinical Trial

— HIP ATTACK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027896
• Other study ID #: HIP ATTACK Trial v5.0
• Status: Completed
• Phase: N/A
• Start date: March 14, 2014
• Est. completion date: September 30, 2022

Study information

• Verified date: January 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HIP ATTACK is an international randomized controlled trial of 3000 patients with a hip fracture that requires a surgical intervention. This trial will determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 90-day risk of mortality and major perioperative complication (i.e., a composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3001
• Est. completion date: September 30, 2022
• Est. primary completion date: August 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• age =45 years; and
• diagnosis of hip fracture during working hours with a low-energy mechanism (i.e., falling from standing height) requiring surgery.

Exclusion Criteria:

• patients requiring emergent surgery or emergent interventions for another reason (e.g., subdural hematoma, abdominal pathology requiring urgent laparotomy, acute limb ischemia, other fractures or trauma requiring emergent surgery, necrotising fasciitis, coronary revascularization, pacemaker-implantation);
• open hip fracture;
• bilateral hip fractures;
• peri-prosthetic fracture;
• therapeutic anticoagulation not induced by a Vitamin K Antagonist, unfractionated heparin, (e.g., administration of therapeutic Low Molecular Weight Heparin (LMWH) (>6,000 u/24h) in the 24 hours prior to enrolment, or intake of any other non-reversible oral anticoagulant(s) for which there is no reversing agent available
• patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);
• patients refusing participation; or
• patients previously enrolled in the study.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Accelerated medical clearance and surgery
Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert
Canada	Royal Victoria Hospital	Barrie	Ontario
Canada	South Health Campus	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Etobicoke General Hospital	Etobicoke	Ontario
Canada	QEII Health Sciences	Halifax,	Nova Scotia
Canada	Hamilton Health Sciences - Juravinski Hospital	Hamilton	Ontario
Canada	St. Joseph's Hospital Hamilton	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Grand River Hospital	Kitchener	Ontario
Canada	Victoria Hospital, London Health Sciences	London	Ontario
Canada	Markham Stouffville Hospital	Markham	Ontario
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Humber River Hospital	Toronto	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Concordia Hip and Knee Institute	Winnipeg,	Manitoba
China	Beijing Chaoyang Hospital	Beijing
Colombia	Fundacion Cardioinfantil	Bogotá
France	Centre Hospitalier Lyon Sud	Lyon
France	Nimes University Hospital	Nîmes Cedex 09
Hong Kong	Queen Mary Hospital	High West
India	Government TD Medical College	Alappuzha
India	Sparsh Hospital	Bangalore
India	PGIMER	Chandigarh
India	Bangalore Baptist Hospital	Hebbal
India	NH Kolkata	Kolkata
India	CMC Ludhiana	Ludhiana
India	Seven Star Hospital	Nagpur
India	AIIMS Hospital	New Delhi
India	JIPMER	Puducherry
India	Sancheti Institute for Orthopaedics and Rehabilitation	Shivajinagar
India	Government Medical Hospital	Trivandrum
Italy	Humanitas Research Hospital	Milan
Italy	IRCCS Galeazzi Orthopedic Institute	Milan
Italy	Ospedale San Raffaele	Milan
Italy	ASST Sette Laghi - Ospedale Di	Varese
Malaysia	Hospital Pulau Pinang	George Town
Malaysia	University Malaya Medical Centre (UMMC)	Kuala Lumpur
Netherlands	Deventer Ziekenhuis	Deventer
Pakistan	Shifa International Hospitals	Islamabad
Pakistan	The Aga Khan University	Karachi
Poland	SPZOZ Szpital Powiatowy w Bochni im M. Wieckiej	Bochnia
Poland	University Hospital & Educational Center of Medical University in Lodz	Lódz
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Myslenicach	Myslenice
South Africa	Groote Schuur Hospital	Cape Town
South Africa	Stellenbosch University	Cape Town
South Africa	Chris Hani Baragwanath Hospital	Johannesburg
Spain	Corporació Sanitària Parc Taulí	Barcelona
Spain	Hospital San Pau	Barcelona
Spain	Hospital Sant Camil (Consorci Sanitari Garraf)	Barcelona
Spain	Hospital Universitaire Vall d'Hebron	Barcelona
Spain	Mutua de Terrassa Hospital	Barcelona
Spain	Costa del Sol	Marbella
Spain	Hospital Clinico Universitario de Vallad	Valladolid
Thailand	Ramathibodi Hospital	Bangkok,
United Kingdom	Calderdale & Huddersfield NHS	Huddersfield
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	West Middlesex Hospital	London
United Kingdom	Peterborough City Hospital	Peterborough
United Kingdom	King's Mill Hospital	Sutton in Ashfield
United States	University of Maryland	Baltimore	Maryland
United States	Lahey Hospital and Medical Centre	Burlington	Massachusetts
United States	Ohio State University Medical Centre	Columbus	Ohio
United States	Regional Medical Center of San Jose	San Jose	California
United States	Tufts Medical Centre	Washington	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, Population Health Research Institute

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  China,  Colombia,  France,  Hong Kong,  India,  Italy,  Malaysia,  Netherlands,  Pakistan,  Poland,  South Africa,  Spain,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite - major perioperative complication	Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding	90 days
Primary	Mortality	All-cause mortality	90 days
Secondary	All-cause mortality	Death due to all causes	90 days and 1 year
Secondary	Vascular mortality	Death due to vascular cause	90 days and 1 year
Secondary	Non-vascular mortality	Death due to non-vascular cause	90 days and 1 year
Secondary	Myocardial infarction	Myocardial infarction	90 days and 1 year
Secondary	Cardiac revascularization procedure	i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] surgery	90 days and 1 year
Secondary	New congestive heart failure	New congestive heart failure	90 days and 1 year
Secondary	New clinically important atrial fibrillation	New clinically important atrial fibrillation	90 days
Secondary	Nonfatal cardiac arrest	Nonfatal cardiac arrest	30 days and 1 year
Secondary	Stroke	Stroke	90 days and 1 year
Secondary	Peripheral arterial thrombosis	Peripheral arterial thrombosis	90 days and 1 year
Secondary	Pulmonary embolism	Pulmonary embolism	90 days and 1 year
Secondary	Deep venous thrombosis	Deep venous thrombosis	90 days and 1 year
Secondary	Pneumonia	Pneumonia	90 days and 1 year
Secondary	Sepsis	Sepsis	90 days and 1 year
Secondary	Infection	Infection	90 days
Secondary	Life-threatening bleeding	Life-threatening bleeding	90 days
Secondary	Major bleeding	Major bleeding	90 days
Secondary	New acute renal failure requiring dialysis	New acute renal failure requiring dialysis	90 days and 1 year
Secondary	Peri-prosthetic fracture	Peri-prosthetic fracture	90 days and 1 year
Secondary	Prosthetic hip dislocation	Prosthetic hip dislocation	90 days and 1 year
Secondary	Implant failure	Implant failure	90 days and 1 year
Secondary	Hip re-operation	Hip re-operation	30 days and 1 year
Secondary	Time to first mobilization	Time to first mobilization	90 days
Secondary	Length of hospital stay	Length of hospital stay	90 days
Secondary	Length of critical care stay	Length of critical care stay	90 days
Secondary	Length of rehabilitation stay	Length of rehabilitation stay	90 days
Secondary	New residence in a nursing home	New residence in a nursing home	90 days and 1 year
Secondary	Functional Independence Measure (FIM™)	Functional Independence Measure (FIM™)	30 days and 1 year
Secondary	SF-36 score	SF-36 score	30 days and 1 year
Secondary	Delirium within 7 days of randomization	Delirium within 7 days of randomization	7 days
Secondary	Hospital readmission	Hospital readmission	90 days and 1 year
Secondary	New pressure ulcers	New pressure ulcers	90 days
Secondary	Incisional pain	Incisional pain	30 days
Secondary	Chronic incisional pain	Chronic incisional pain	1 year
Secondary	Acute Kidney Injury	Acute Kidney Injury	90 Day
Secondary	Acute Kidney Injury	Acute Kidney Injury	1 Year
Secondary	Mortality and Institutionalization status of dependents	Mortality and Institutionalization status of dependents	30 Days
Secondary	Mortality and Institutionalization status of dependents	Mortality and Institutionalization status of dependents	1 Year
Secondary	Economic Analysis	Economic Analysis	90 Days and 1 Year
Secondary	Health System Utilization, Long Term Follow up	Health System Utilization, Long Term Follow up	2, 5, 10 Years

External Links

•   HIP ATTACK Pilot Canadian Medical Association Journal (CMAJ) Publication