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Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
Led by Major Extremity Trauma Research Consortium · Updated on 2025-08-28
60
Participants Needed
4
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether tissue ultrafiltration (TUF) catheters can reduce muscle pressure and prevent acute compartment syndrome (ACS) in adults aged 18 to 60 who have severe fractures of the upper leg, including the proximal tibia or tibial shaft. The study aims to compare intramuscular pressure levels, the likelihood of developing ACS, the need for fasciotomy surgery, and functional recovery six months after injury between patients receiving TUF catheters and those receiving standard care. It also investigates whether fluid biomarkers collected from the muscle tissue can predict ACS. The study involves 60 participants randomized into two groups: one group receives standard care with continuous pressure monitoring of the leg muscle compartment, while the other group receives the same care plus three TUF catheters placed in the injured leg to remove interstitial fluid. Participants must be enrolled within 14 hours of injury or before surgery related to their fracture within 48 hours. Both groups receive ongoing clinical evaluations, and the TUF catheters are connected to a closed suction system to remove fluid from the muscle. During the study, participants will be monitored continuously for muscle pressure and treated according to standard medical practices for their injuries. They will return for a follow-up visit six months after hospital discharge to assess complications, healing progress, muscle function, and patient-reported health outcomes. A subset of patients will provide fluid samples for biomarker analysis. The main outcome measured is the difference in muscle pressure at six months, alongside secondary outcomes like ACS incidence, surgery rates, and physical function improvements.
CONDITIONS
Brief Title
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- High-energy upper leg injury such as open or closed proximal tibial shaft fracture with displacement, comminution, or segmental pattern, proximal fibula fracture, bicondylar tibial plateau fracture, Schatzker IV medial knee fracture-dislocation, proximal leg injury from projectile or severe crushing
- Enrollment within 14 hours of injury or prior to surgical fixation within 48 hours of admission
- Willingness to provide informed consent
You will not qualify if you...
- Unwillingness to participate
- Non-traumatic acute compartment syndrome cases (e.g., severe exertion, snakebite, high-pressure injection injury)
- Diagnosed with ACS or imminent ACS requiring immediate fasciotomy
- Soft tissue wounds interfering with catheter placement on the front or anterolateral leg
- Unlikely to follow up (homeless, incarcerated, or living out-of-state)
- Known peripheral vascular disease
- Non-ambulatory due to spinal cord injury or pre-existing conditions
- Very low clinical concern for ACS at admission
AI-Screening
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Your Study Journey
Duration - Up to 14 hours from injury or prior to surgery within 48 hours of injury
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - During initial hospital stay post-injury
Participants randomized to the experimental group will have three tissue ultrafiltration (TUF) catheters placed in the injured muscle compartment. All participants will have continuous pressure monitoring and receive standard-of-care treatment for their injury and risk of acute compartment syndrome (ACS).
Hospital visits as part of treatment and monitoring
Duration - 6 months post-injury
Participants are followed for up to 6 months after hospital discharge to evaluate complications, healing, muscle function, and patient-reported outcomes.
1 follow-up visit at 6 months (in-person)
Trial Site Locations
Total: 4 locations
1
University of Maryland School of Medicine R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States, 55415-1623
Actively Recruiting
3
Atrium Health Musculoskeletal Institute
Charlotte, North Carolina, United States, 28207
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
D
Dana Alkhoury, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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