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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 19, 2014
Last verified: August 2014

January 2, 2014
August 19, 2014
March 2014
March 2016   (final data collection date for primary outcome measure)
Composite - major perioperative complication [ Time Frame: 30 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Vascular mortality [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Non-vascular mortality [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Cardiac revascularization procedure [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
    i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] surgery
  • Congestive heart failure [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • New clinically important atrial fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Nonfatal cardiac arrest [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Peripheral arterial thrombosis [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Pulmonary embolism [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Deep venous thrombosis [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Pneumonia [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Sepsis [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Life-threatening bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • New acute renal failure requiring dialysis [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Peri-prosthetic fracture [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Prosthetic hip dislocation [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Implant failure [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Hip re-operation [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Time to first mobilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of critical care stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Length of rehabilitation stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • New residence in a nursing home [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Functional Independence Measure (FIM™) [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • SF-36 score [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
  • Delirium within 7 days of randomization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hospital readmission [ Time Frame: 30 days and 1 year ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
March 2017
March 2016   (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 warfarin or unfractionated heparin, (e.g., administration of therapeutic Low Molecular Weight Heparin (LMWH) (>6,000 u/24h) in the 24 hours prior to enrolment or any intake of Dabigatran, Apixaban, Rivaroxaban, or Edoxaban);
  • 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.
Both
45 Years and older
No
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
Canada
 
NCT02027896
HIP ATTACK Trial v1.0
No
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 2014

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