Status:
COMPLETED
Patient-Specific Precision Injury Signatures in Multiply Injured Orthopaedic Patients
Lead Sponsor:
Major Extremity Trauma Research Consortium
Collaborating Sponsors:
United States Department of Defense
Conditions:
Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries
Eligibility:
All Genders
18-55 years
Brief Summary
The purpose of this study is to evaluate the use of precision methods that quantify injury and response to injury to predict how short-term clinical outcomes are affected by initial and staged orthopa...
Detailed Description
There is currently a knowledge gap regarding in the treatment of the severely injured MIP, as clinicians are often challenged by when non-life threatening orthopaedic procedures should be performed. I...
Eligibility Criteria
Inclusion
- Adult ages 18 years old to 55 years old inclusive;
- Direct admission to hospital from scene of injury, or if transferred, admitted no more than 6 hours from injury
- Full trauma activation with either direct admission to Intensive Care Unit (ICU) or other higher level of care, or taken directly to surgery and admitted to ICU after surgery;
- Sustaining at least one operative orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia with planned definitive fixation to occur prior to discharge.
Exclusion
- Non-survivable head trauma.
- Signs of severe traumatic brain injury indicated by a GCS of \< 7 at the time of admission and no improvement in the GCS by the time of consent.
- Spinal cord injury with likely permanent neurologic deficits
- Pre-existing organ dysfunction or failure prior to their injury, including but not limited to end-stage renal disease, liver failure, congestive heart failure, or severe COPD requiring home oxygen.
- Qualifying orthopaedic injury primarily a periarticular fracture (tibial pilon or plateau) with planned delay to definitive fixation for soft tissue reasons.
- Primary blood draw could not be obtained within 3 hours of presentation
- Patient is pregnant
- Patient is a prisoner/incarcerated
- Patient or legally authorized representative (LAR) unable to provide consent prior to 48 hour blood draw.
Key Trial Info
Start Date :
March 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2023
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03772730
Start Date
March 20 2019
End Date
May 30 2023
Last Update
October 18 2023
Active Locations (8)
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1
University of Miami Ryder Trauma Center
Miami, Florida, United States, 33101
2
Methodist Hospital/Indiana University
Indianapolis, Indiana, United States, 46202
3
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
4
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201