Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
Major Extremity Trauma Research Consortium
Summary
The goal of this clinical trial is to learn if tissue ultrafiltration (TUF) catheters can reduce intramuscular pressure and prevent acute compartment syndrome (ACS) in adults ages 18-60 with severe proximal tibia or tibial shaft fractures. The main questions it aims to answer are: Will intramuscular pressure (IMP) be lower in the TUF cohort compared to controls? Will the consensus likelihood of ACS, incidence of fasciotomy, and 6-month functional outcomes be better in the TUF cohort? Are interstitial fluid biomarkers predictive of ACS? Researchers will compare patients randomized to TUF catheters (n=30) versus control patients receiving standard-of-care only (n=30) to see if TUF lowers ACS risk and improves recovery. Participants will: Be enrolled within 14 hours of injury or prior to high-risk surgery within 48 hours. Receive continuous anterior compartment pressure monitoring. Undergo standard-of-care clinical evaluation and treatment. (TUF arm only) Have three TUF catheters placed in the injured limb to remove interstitial fluid. Return for a 6-month follow-up to assess complications, healing, muscle function, and patient-reported outcomes. (Hennepin Healthcare subset) Provide interstitial fluid samples for biomarker analysis.
Description
The study will enroll 60 adults ages 18-60 admitted to the hospital with severe open or closed fractures of the proximal tibia or tibial shaft at risk for ACS. Participants will be randomized to either treatment with tissue ultrafiltration (TUF) catheters (n=30) or to a control group (n=30). Patients will be enrolled within 14 hours of initial injury, or just prior to undergoing surgical procedures that are associated with a risk of post-operative ACS within 48 hours of injury. All patients will receive continuous pressure monitoring of the anterior compartment of their leg. Both groups will r…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA The target population for this study include adults ages 18-60 with high-energy injuries of the upper leg considered at risk for ACS at time of admission by virtue of their mechanism of injury, fracture pattern, clinical signs, or need to undergo fracture fixation surgery (internal or external fixation) within 48 hours of admission. Recruitment of participants will happen during hospital admission for treatment of injury. Eligible patients must meet all of the following criteria and be enrolled during one of two possible times: within 14 hours of injury, or prior to undergo…
Interventions
- DeviceTissue Ultrafiltration Catheters
patients randomized to the experimental arm will have three TUF catheters placed in the anterior muscle compartment of the injured limb. The TUF catheters will be connected to a closed suction drain and will remove interstitial fluid from the muscle.
Locations (4)
- University of Maryland School of Medicine R Adams Cowley Shock Trauma CenterBaltimore, Maryland
- Hennepin Healthcare Research InstituteMinneapolis, Minnesota
- Atrium Health Musculoskeletal InstituteCharlotte, North Carolina
- Vanderbilt University Medical CenterNashville, Tennessee