A Multi-Center, Prospective Observational Study to Evaluate the Use of Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients (PRECISE)

Study on Body Responses to Traumatic Orthopaedic Injuries

Enrolling By Invitation
18 years - 55 years
All

Brief description of study.

The purpose of the PRECISE study (A multi-center, prospective observational study to evaluate the use of Patient-Specific Precision Injury Signatures to Optimize Orthopaedic Interventions in Multiply Injured Patients) is to evaluate how the human body responds to trauma and to treatment for traumatic injuries.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Trauma injury
  • Age: 18 years - 55 years
  • Gender: All

Inclusion Criteria

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 Criteria

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 at 48hr after admission.
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.

This study investigates how the human body responds to trauma and the treatments for traumatic injuries, focusing on orthopaedic injuries. The purpose is to understand the body's reaction to such injuries and the subsequent medical interventions. Orthopaedic injuries refer to damage to the bones, muscles, or joints, which can occur in areas like the pelvis, femur, or tibia.

Participants in the study will undergo specific procedures, including blood draws and monitoring of their condition. Blood draws involve taking a small sample of blood to analyze how the body is responding to the injury and treatment. The study will also involve tracking the recovery process after surgeries related to orthopaedic injuries.

  • Who can participate: Adults admitted to the hospital within 6 hours of a severe orthopaedic injury requiring surgery can participate. They must be directly admitted to the ICU or taken to surgery immediately, without severe brain injuries or pre-existing organ failures.
  • Study details: Participants will have their blood drawn and monitored as part of the study to evaluate the body's response to injury and medical interventions. The study focuses on orthopaedic injuries requiring surgery.
Updated on 19 Feb 2024. Study ID: 1806066897

Interested in the study?

study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact a study center.