Actively Recruiting
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
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Have a 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 due to shotgun, rifle, or other projectile, or severe crushing injury
- Enrollment possible within 14 hours of injury or before urgent surgical fixation within 48 hours of admission
- Willing to sign informed consent or have an authorized representative who can consent
You will not qualify if you...
- Patients unwilling to participate
- Non-traumatic acute compartment syndrome cases (e.g., severe exertion, snakebite, high-pressure injection injury)
- Diagnosed with ACS or impending ACS requiring immediate fasciotomy
- Soft tissue wounds at catheter insertion sites (anterior or anterolateral leg) that interfere with safe catheter placement
- Unlikely to follow up due to homelessness, incarceration, or living out-of-state
- Known peripheral vascular disease
- Non-ambulatory due to complete spinal cord injury or pre-existing condition
- Very low clinical concern for ACS at admission
AI-Screening
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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
CONTACT
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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