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

NCT05889559 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-28

No results posted yet for this study

Summary

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

  • Acute Compartment Syndrome
  • Fracture, Bone
  • Tibial Fractures

Interventions

DEVICE

Tissue Ultrafiltration Catheters

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.

Sponsors & Collaborators

  • Major Extremity Trauma Research Consortium

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-01-01
Completion
2026-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05889559 on ClinicalTrials.gov