Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk … (NCT05889559) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
United States60 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Between the ages of 18 and 60 years
✓. Have sustained a high-energy upper leg injury such as open or closed proximal tibial shaft fracture with displacement, comminution, or segmental pattern; proximal fibula fracture; bicondylar tibial plateau fracture; Schatzker IV medial knee fracture-dislocation; proximal leg injury due to shotgun, rifle, or other projectile, or severe crushing injury.
✓. Patient can be enrolled in the study and study procedures initiated within 14 hours of injury,\* or be enrolled prior to undergoing urgent surgical intervention on the injured limb (defined as internal or external fixation) within 48 hours of admission.
. Soft tissue wounds, including lacerations or abrasions, that are in a location that will interfere with safe insertion of indwelling pressure or TUF catheters (anterior - anterolateral aspect of the leg)
✕. Patients not likely to follow-up (are homeless, incarcerated, live out-of-state).
✕. Patients with known peripheral vascular disease
✕. Non-ambulatory due to an associated complete spinal cord injury; Non-ambulatory before the injury due to a pre-existing condition.
✕. Very low clinical concern for ACS at time of admission.