Patient-Specific Precision Injury Signatures in Multiply Injured Orthopaedic Patients

NCT03772730 | Completed DMC

• 1 other identifier: 00008259
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 8

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

Conditions

Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries

Outcome Measures

Primary Outcomes (1)

• Clinical outcomes recorded during 6month post injury medical record review

  Number of occurrences of multiple organ dysfunction, nosocomial infection, wound complications, resource utilization and death as noted in medical record review.

  6 months post injury

Study Arms (1)

Group 1

Multiply injured patients having at least one operative orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia with planned definitive fixation to occur prior to discharge.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult (18-55) patients sustaining multiple injuries, including at least one qualifying orthopaedic injury to the pelvis, acetabulum, femur, or diaphyseal tibia.

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.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead
• United States Department of Defense: collaborator

Study Sites (8)

University of Miami Ryder Trauma Center

Miami, Florida, 33101, United States

Location

Methodist Hospital/Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

University of Maryland, R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Carolinas Medical Center

Durham, North Carolina, 28232, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

UT Health: The University of Texas Health Science Center at Houston Medical School

Houston, Texas, 77030, United States

Location

University of Washington Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Todd McKinley, MD

  Indiana University/Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: March 20, 2019
• Primary Completion: September 30, 2022
• Study Completion: May 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (8)