Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03772730
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2018-12-07
Brief Title:
Patient-Specific Precision Injury Signatures in Multiply Injured Orthopaedic Patients
Sponsor:
Major Extremity Trauma Research Consortium
Organization:
Major Extremity Trauma Research Consortium
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECISE
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
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 Information to guide orthopaedic interventions in MIPs is based primarily on resuscitation parameters and injury severity metricsLack 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 NIH36 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
1 Multiple organ dysfunction
2 Nosocomial infection
3 Wound complications
4 Resource utilization ICUhospital LOS days on mechanical ventilation discharge disposition
5 Death
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 timingmagnitude 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
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 NIH36 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
1 Multiple organ dysfunction
2 Nosocomial infection
3 Wound complications
4 Resource utilization ICUhospital LOS days on mechanical ventilation discharge disposition
5 Death
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 timingmagnitude 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None