RECRUITING

HIP Fracture Accelerated Surgical TreaTment and Care TracK 2 Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

Official Title

HIP Fracture Accelerated Surgical TreaTment and Care TracK 2 (HIP ATTACK-2) Trial

Quick Facts

Study Start:2021-11-22
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04743765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. age ≥45 years;
  2. 2. diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;
  3. 3. troponin elevation ( at least one troponin measurement above the upper limit of normal occurring from the time of hip fracture to the time of randomization); and
  4. 4. informed consent.
  1. 1. taking a therapeutic dose of an anticoagulant for which no reversing agent is available and the anesthesiologist or surgeon believe surgery within 6 hours of eligibility criteria met would not be safe;
  2. 2. patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);
  3. 3. patients with peri-prosthetic fracture, open fracture or bilateral fractures;
  4. 4. patients requiring an emergency surgery for another reason (e.g., subdural hematoma);
  5. 5. patients with acute myocardial infarction deemed to be clinically unstable, with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect), ST elevation myocardial infarction, or cardiogenic shock;
  6. 6. patients refusing consent; or
  7. 7. patients previously enrolled in HIP ATTACK-2.

Contacts and Locations

Study Contact

Valerie Harvey
CONTACT
905-297-3479
valerie.harvey@phri.ca

Principal Investigator

Flavia Borges, M.D
PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Gerard Slobogean, M.D
PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Robert Feibel, M.D
PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
PJ Devereaux, M.D
STUDY_CHAIR
Population Health Research Institute

Study Locations (Sites)

The Regents of the University of California
Davis, California, 95618
United States
University of Maryland
Baltimore, Maryland, 20742
United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Bryan Medical Center
Lincoln, Nebraska, 68506
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Wisconsin
Madison, Wisconsin, 53715
United States

Collaborators and Investigators

Sponsor: Population Health Research Institute

  • Flavia Borges, M.D, PRINCIPAL_INVESTIGATOR, Population Health Research Institute
  • Gerard Slobogean, M.D, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore
  • Robert Feibel, M.D, PRINCIPAL_INVESTIGATOR, The Ottawa Hospital
  • PJ Devereaux, M.D, STUDY_CHAIR, Population Health Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-22
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2021-11-22
Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hip Fractures
  • Myocardial Injury