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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by McMaster University
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
McMaster University ( Population Health Research Institute )
ClinicalTrials.gov Identifier:
NCT02027896
First received: January 2, 2014
Last updated: December 20, 2016
Last verified: December 2016
  Purpose
HIP ATTACK is an international randomized controlled trial of 1200 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 30-day risk of a 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).

Condition Intervention
Hip Fractures
Other: Accelerated medical clearance and surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Composite - major perioperative complication [ Time Frame: 30 days ]
    Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding


Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 30 days and 1 year ]
  • Vascular mortality [ Time Frame: 30 days and 1 year ]
  • Non-vascular mortality [ Time Frame: 30 days and 1 year ]
  • Myocardial infarction [ Time Frame: 30 days and 1 year ]
  • Cardiac revascularization procedure [ Time Frame: 30 days and 1 year ]
    i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] surgery

  • New congestive heart failure [ Time Frame: 30 days and 1 year ]
  • New clinically important atrial fibrillation [ Time Frame: 30 days ]
  • Nonfatal cardiac arrest [ Time Frame: 30 days and 1 year ]
  • Stroke [ Time Frame: 30 days and 1 year ]
  • Peripheral arterial thrombosis [ Time Frame: 30 days and 1 year ]
  • Pulmonary embolism [ Time Frame: 30 days and 1 year ]
  • Deep venous thrombosis [ Time Frame: 30 days and 1 year ]
  • Pneumonia [ Time Frame: 30 days and 1 year ]
  • Sepsis [ Time Frame: 30 days and 1 year ]
  • Infection [ Time Frame: 30 days ]
  • Life-threatening bleeding [ Time Frame: 30 days ]
  • Major bleeding [ Time Frame: 30 days ]
  • New acute renal failure requiring dialysis [ Time Frame: 30 days and 1 year ]
  • Peri-prosthetic fracture [ Time Frame: 30 days and 1 year ]
  • Prosthetic hip dislocation [ Time Frame: 30 days and 1 year ]
  • Implant failure [ Time Frame: 30 days and 1 year ]
  • Hip re-operation [ Time Frame: 30 days and 1 year ]
  • Time to first mobilization [ Time Frame: 30 days ]
  • Length of hospital stay [ Time Frame: 30 days ]
  • Length of critical care stay [ Time Frame: 30 days ]
  • Length of rehabilitation stay [ Time Frame: 30 days ]
  • New residence in a nursing home [ Time Frame: 30 days and 1 year ]
  • Functional Independence Measure (FIM™) [ Time Frame: 30 days and 1 year ]
  • SF-36 score [ Time Frame: 30 days and 1 year ]
  • Delirium within 7 days of randomization [ Time Frame: 30 days ]
  • Hospital readmission [ Time Frame: 30 days and 1 year ]
  • New pressure ulcers [ Time Frame: 30 days ]
  • Incisional pain [ Time Frame: 30 days ]
  • Chronic incisional pain [ Time Frame: 1 year ]
  • Acute Kidney Injury [ Time Frame: 30 Day ]
  • Acute Kidney Injury [ Time Frame: 1 Year ]
  • Mortality and Institutionalization status of dependents [ Time Frame: 30 Days ]
  • Mortality and Institutionalization status of dependents [ Time Frame: 1 Year ]
  • Economic Analysis [ Time Frame: 30 Days and 1 Year ]
  • Health System Utilization, Long Term Follow up [ Time Frame: 2, 5, 10 Years ]

Estimated Enrollment: 1200
Study Start Date: March 2014
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
No Intervention: Standard surgical care
Surgical hip fracture repair according to the standard timing.

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027896

Contacts
Contact: Valerie Dunlop, BS.c 905-527-4322 ext 40675 valerie.dunlop@phri.ca
Contact: Shirley Pettit, RN 905-527-4322 ext 40526 shirley.pettit@phri.ca

Locations
Belgium
Cliniques Universitaires Saint-Luc Not yet recruiting
Brussels, Belgium
Canada, Ontario
Etobicoke General Hospital Active, not recruiting
Etobicoke, Ontario, Canada
St. Joseph's Hospital Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Kelly Lawrence    905-522-1155 ext 33091    lawrence@hhsc.ca   
Principal Investigator: Maria Tiboni, MD         
Principal Investigator: John Neary, MD         
Hamilton Health Sciences - Juravinski Hospital Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Krysten Gregus, RPN    905-527-4322 ext 67177    gregus@hhsc.ca   
Principal Investigator: Ameen Patel, MD         
Principal Investigator: Vikas Tandon, MD         
Victoria Hospital, London Health Sciences Recruiting
London, Ontario, Canada
Markham Stouffville Hospital Recruiting
Markham, Ontario, Canada
Thunder Bay Regional Health Sciences Recruiting
Thunder Bay, Ontario, Canada
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Richard Jenkinson, MD         
Vancouver General Hospital Not yet recruiting
Vancouver, Ontario, Canada
Pakistan
Shifa International Hospitals Recruiting
Islamabad, Pakistan
Spain
Hospital Universitaire Vall d'Hebron Recruiting
Barcelona, Spain
Sponsors and Collaborators
Population Health Research Institute
McMaster University
Investigators
Principal Investigator: Philip J Devereaux, MD, PhD McMaster University
Principal Investigator: Mohit Bhandari, MD, PhD McMaster University
  More Information

Additional Information:
Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02027896     History of Changes
Other Study ID Numbers: HIP ATTACK Trial v4.0
Study First Received: January 2, 2014
Last Updated: December 20, 2016

Keywords provided by McMaster University:
Perioperative outcomes

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 21, 2017