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Accelerated Surgery for Hip Fracture (HIP ATTACK-2 Trial)

N/A
Recruiting
Led By Robert Feibel, M.D
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery
age ≥45 years
Must not have
patients requiring an emergency surgery for another reason (e.g., subdural hematoma)
patients with peri-prosthetic fracture, open fracture or bilateral fractures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 7 days and 90 days post randomization
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare accelerated surgery for hip fracture in patients with acute myocardial injury to standard care, in order to determine if it is superior in reducing death.

Who is the study for?
This trial is for individuals aged 45 or older who have a hip fracture from a low-energy event and need surgery, with elevated troponin levels indicating heart muscle injury. It's not for those with certain types of severe heart attacks, on specific anticoagulants without reversal options, refusing consent, previously enrolled in the same trial, needing emergency surgeries for other reasons, or with particular fracture types.
What is being tested?
The HIP ATTACK-2 trial is testing if getting surgery faster than usual for a hip fracture in patients who also have acute myocardial injury leads to better outcomes like lower death rates at 90 days post-surgery. It will also look at mobility recovery time, complications such as heart failure and stroke, delirium occurrence, pain levels and overall quality of life.
What are the potential side effects?
While the study doesn't list specific side effects related to accelerated medical clearance and surgery itself beyond typical surgical risks (like infection or bleeding), it will monitor major complications including new heart attacks, congestive heart failure events and strokes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a hip fracture from a low-energy incident needing surgery.
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I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need emergency surgery for a condition unrelated to the trial.
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I have a fracture around a joint replacement, an open fracture, or fractures on both sides.
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I have had a heart attack with complications like muscle rupture or shock.
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I am on a blood thinner that cannot be easily reversed.
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I am taking vitamin K for blood clots but have had a bad reaction to heparin before.
Select...
I do not agree to participate in this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days and 90 days post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 7 days and 90 days post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Perinatal death
Secondary study objectives
Ability to independently walk 3 meters
Acute Congestive Heart Failure
Composite of major complications
+7 more
Other study objectives
Acute kidney injury
Acute renal failure resulting in dialysis
Bleeding
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Accelerated medical clearance and surgeryExperimental Treatment1 Intervention
Accelerated medical clearance and targeted arrival to the operating room within 6 hours of eligibility criteria met.
Group II: Standard surgical careActive Control1 Intervention
Hip fracture repair and surgical care according to treating institution guidelines.

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,088,918 Total Patients Enrolled
2 Trials studying Hip Fracture
80 Patients Enrolled for Hip Fracture
Population Health Research InstituteLead Sponsor
164 Previous Clinical Trials
717,414 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,526,366 Total Patients Enrolled
Robert Feibel, M.DPrincipal InvestigatorThe Ottawa Hospital
PJ Devereaux, M.DStudy ChairPopulation Health Research Institute
Flavia Borges, M.DPrincipal InvestigatorPopulation Health Research Institute
Gerard Slobogean, M.DPrincipal InvestigatorUniversity of Maryland, Baltimore

Media Library

Accelerated medical clearance and surgery Clinical Trial Eligibility Overview. Trial Name: NCT04743765 — N/A
Hip Fracture Research Study Groups: Accelerated medical clearance and surgery, Standard surgical care
Hip Fracture Clinical Trial 2023: Accelerated medical clearance and surgery Highlights & Side Effects. Trial Name: NCT04743765 — N/A
Accelerated medical clearance and surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743765 — N/A
~454 spots leftby Feb 2027
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