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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Major Extremity Trauma Research Consortium
Study ID
NCT05889559
Status
Recruiting
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Conditions

  • Acute Compartment Syndrome
  • Fracture, Bone
  • Tibial Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Tissue Ultrafiltration Catheters — DEVICE
    patients randomized to the experimental arm will have three TUF catheters placed in the anterior muscle compartment of the injured limb. The TUF catheters will be connected to a closed suction drain and will remove interstitial fluid from the muscle.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Aug 2025
Primary completion
Jan 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control Pressure Monitoring Group
    Participants in this group will have pressure monitoring of the anterior compartment of their leg using an indwelling IMP catheter (MY01, MY01 Inc., Montreal, CA). The participants will be treated according to the standard-of-care regarding management of their underlying injury and diagnosis of ACS as practiced by their treating surgeon. Participants will be followed for six months post-injury.
  • Experimental: Tissue Ultrafiltration Intervention Group (TUF)
    Participants in this group will have pressure monitoring of the anterior compartment of their leg using an indwelling IMP catheter (MY01, MY01 Inc., Montreal, CA). The participants will be treated according to the standard-of-care regarding management of their underlying injury and diagnosis of ACS as practiced by their treating surgeon. In addition, participants in this group will will undergo three TUF of the anterior compartment of the injured limb. Participants will be followed for six months post-injury.

Primary Outcome Measure

To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients. [ Time Frame: 6 months post injury ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Maryland School of Medicine R Adams Cowley Shock Trauma CenterBaltimoreMaryland21201-
Hennepin Healthcare Research InstituteMinneapolisMinnesota55415-1623-
Atrium Health Musculoskeletal InstituteCharlotteNorth Carolina28207-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Baltimore, MD

By research site
University of Maryland School of Medicine R Adams Cowley Shock Trauma Center· Baltimore, MDHennepin Healthcare Research Institute· Minneapolis, MNAtrium Health Musculoskeletal Institute· Charlotte, NCVanderbilt University Medical Center· Nashville, TN

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