Patient-Specific Precision Injury Signatures in Multiply Injured Orthopaedic Patients (PRECISE)
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|ClinicalTrials.gov Identifier: NCT03772730|
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : February 28, 2019
|Condition or disease|
|Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries|
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. Information to guide orthopaedic interventions in MIPs is based primarily on resuscitation parameters and injury severity metrics.Lack of consensus among surgeons regarding choices of orthopaedic interventions reflects the paucity of data to form treatment decisions.
This study will define the key parameters affecting these decisions in a quantitative manner by exploring the efficacy of a precision medicine approach to guide surgical decisions in multiply injured patients (MIPs) with skeletal trauma. According to the National Institutes of Health (NIH),36 precision medicine is "an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person." This approach will allow clinicians and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people. The application of precision medicine will bring to bear evidence-based tools that can guide decisions facing the treating surgeons regarding the optimal timing of definitive fracture surgery after injury, as well as defining the magnitude of surgical intervention which may be pursued without engendering clinical complications.
Specific Aim 1: Define groups of patients based on Precision Injury Signatures (mechanical and ischemic injury characteristics and immunologic response profile) that correspond to the following short term clinical outcomes;
- Multiple organ dysfunction
- Nosocomial infection
- Wound complications
- Resource utilization (ICU/hospital LOS, days on mechanical ventilation, discharge disposition)
Hypothesis 1: Patients who develop complicated short term outcomes will demonstrate distinct Precision Injury Signatures compared to patients who have uncomplicated outcomes for injuries of similar magnitude.
Specific Aim 2: Evaluate the impact of timing and magnitude of orthopaedic surgical interventions on progression of patient-specific physiologic and immunologic response. Describe changes in physiologic and immunologic response after initial and staged orthopaedic interventions.
Hypothesis 2: Immunologic and physiologic response to surgery will be a function of initial Precision Injury Signature and timing/magnitude of orthopaedic surgical interventions.
Specific Aim 3: To develop surgical decision rules related to timing of definitive orthopaedic intervention that optimize short term clinical outcomes.
Hypothesis 3a: Initial Precision Injury Signatures can be used to identify orthopaedic trauma patients who are best treated with early definitive treatment or staged definitive intervention.
Hypothesis 3b: Progression of Precision Injury Signatures can be used to determine optimal timing and choices of definitive orthopaedic interventions.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||A Multi-Center, Prospective Observational Study to Evaluate the Use of Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients|
|Estimated Study Start Date :||March 30, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||September 30, 2022|
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.
- Clinical outcomes recorded during 6month post injury medical record review [ Time Frame: 6 months post injury ]Number of occurrences of multiple organ dysfunction, nosocomial infection, wound complications, resource utilization and death as noted in medical record review.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772730
|Contact: Todd McKinley, MDfirstname.lastname@example.org|
|United States, Florida|
|University of Miami Ryder Trauma Center||Not yet recruiting|
|Miami, Florida, United States, 33101|
|United States, Indiana|
|Methodist Hospital/Indiana University||Not yet recruiting|
|Indianapolis, Indiana, United States, 46202|
|United States, Kentucky|
|University of Kentucky Medical Center||Not yet recruiting|
|Lexington, Kentucky, United States, 40536|
|United States, Maryland|
|University of Maryland, R Adams Cowley Shock Trauma Center||Not yet recruiting|
|Baltimore, Maryland, United States, 21201|
|United States, North Carolina|
|Carolinas Medical Center||Not yet recruiting|
|Durham, North Carolina, United States, 28232|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|UT Health: The University of Texas Health Science Center at Houston Medical School||Not yet recruiting|
|Houston, Texas, United States, 77030|
|United States, Washington|
|University of Washington Harborview Medical Center||Not yet recruiting|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Todd McKinley, MD||Indiana University/Methodist Hospital|