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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 August 2017 by McMaster University ( Population Health Research Institute )
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: August 24, 2017
Last verified: August 2017
January 2, 2014
August 24, 2017
March 2014
December 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02027896 on ClinicalTrials.gov Archive Site
  • All-cause mortality [ Time Frame: 30 days and 1 year ]
    Death due to all causes
  • Vascular mortality [ Time Frame: 30 days and 1 year ]
    Death due to vascular cause
  • Non-vascular mortality [ Time Frame: 30 days and 1 year ]
    Death due to non-vascular cause
  • Myocardial infarction [ Time Frame: 30 days and 1 year ]
    Myocardial infarction
  • 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 ]
    New clinically important atrial fibrillation
  • 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 ]
  • 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
  • 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 ]
Not Provided
Not Provided
 
HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial
HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial
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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Hip Fractures
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.
  • 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.
    Intervention: Other: Accelerated medical clearance and surgery
  • No Intervention: Standard surgical care
    Surgical hip fracture repair according to the standard timing.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
December 2018
December 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
45 Years and older   (Adult, Senior)
No
Contact: Jessica Vincent, MSc 905-527-4322 ext 40635 jessica.vincent@phri.ca
Belgium,   Canada,   Colombia,   France,   India,   Italy,   Malaysia,   Pakistan,   Poland,   South Africa,   Spain,   Thailand,   United Kingdom,   United States,   Venezuela
 
 
NCT02027896
HIP ATTACK Trial v4.0
Yes
Not Provided
Not Provided
McMaster University ( Population Health Research Institute )
Population Health Research Institute
McMaster University
Principal Investigator: Philip J Devereaux, MD, PhD McMaster University
Principal Investigator: Mohit Bhandari, MD, PhD McMaster University
McMaster University
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP