Patient-Specific Precision Injury Signatures in Multiply Injured Orthopaedic Patients

Completed

Conditions studied: Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries

In brief

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 orthopaedic interventions in multiply injured patients (MIPs) who sustain major orthopaedic trauma.

Key facts

Study ID

NCT03772730

Run by

Major Extremity Trauma Research Consortium

People needed

320

Starts

2019-03-20

Expected to finish

2023-05-30

Last updated by the study team

2023-10-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Miami Ryder Trauma Center — Miami, Florida, United States
• Methodist Hospital/Indiana University — Indianapolis, Indiana, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• Carolinas Medical Center — Durham, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• UT Health: The University of Texas Health Science Center at Houston Medical School — Houston, Texas, United States
• University of Washington Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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