Condition: Acute Compartment Syndrome · Fracture, Bone · Tibial Fractures · Sponsor: Major Extremity Trauma Research Consortium
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.
This description comes directly from the study's public registry record.
Dana Alkhoury, MPH · (410) 955-7498 · dalkhou1@jhu.edu
Always discuss trial participation with your own doctor first.
| University of Maryland School of Medicine R Adams Cowley Shock Trauma Center | Baltimore, Maryland, United States | Recruiting |
| Hennepin Healthcare Research Institute | Minneapolis, Minnesota, United States | Recruiting |
| Atrium Health Musculoskeletal Institute | Charlotte, North Carolina, United States | Recruiting |
| Vanderbilt University Medical Center | Nashville, Tennessee, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05889559