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
  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
Endpoint Classification: Efficacy Study
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 ] [ 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1200
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (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
Genders Eligible for Study:   Both
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 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.
  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
Canada, Ontario
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         
St. Joseph's Hospital Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Will Dechert    905-522-1155 ext 33091    dechert@hhsc.ca   
Principal Investigator: Maria Tiboni, MD         
Principal Investigator: John Neary, MD         
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:
No publications provided

Responsible Party: McMaster University ( Population Health Research Institute )
ClinicalTrials.gov Identifier: NCT02027896     History of Changes
Other Study ID Numbers: HIP ATTACK Trial v1.0
Study First Received: January 2, 2014
Last Updated: August 19, 2014
Health Authority: Canada: Ethics Review Committee

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 October 19, 2014