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

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated August 28, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 7 more changesShow less
    • Enrollment target: 200 to 60
    • Primary completion date: Jan 1, 2025 to Jan 1, 2026
    • Primary endpoint revised
    • Study sites: 0 to 4
    • Eligibility criteria expanded, about 108 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 47 words
  2. Start date: Oct 1, 2023 to Jan 1, 2024v3
  3. Start date: Aug 1, 2023 to Oct 1, 2023v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05889559
Lead Sponsor Major Extremity Trauma Research Consortium
Conditions
(from sponsor)		 Acute Compartment Syndrome, Fracture, Bone, Tibial Fractures
Related terms Fractures, Bone, Tibial Fractures
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov