Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)

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.

NCT Number	NCT05889559
Lead Sponsor	Major Extremity Trauma Research Consortium
Conditions	Acute Compartment Syndrome, Fracture, Bone, Tibial Fractures
Enrollment	60 participants
Start Date	2024-01-01
Primary Completion	2026-01-01 (estimated)
Study Completion	2026-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-08-28