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

The study will enroll 60 adults ages 18-60 admitted to the hospital with severe open or closed fractures of the proximal tibia or tibial shaft at risk for ACS. Participants will be randomized to either treatment with tissue ultrafiltration (TUF) catheters (n=30) or to a control group (n=30). Patients will be enrolled within 14 hours of initial injury, or just prior to undergoing surgical procedures that are associated with a risk of post-operative ACS within 48 hours of injury. All patients will receive continuous pressure monitoring of the anterior compartment of their leg. Both groups will receive comprehensive clinical evaluation and 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, 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. All patients will be followed at 6 months following initial hospital discharge. This visit will include a clinical evaluation of complications, hospital admission and emergency room visits, wound and fracture healing, infection, muscle sensory and function exam and patient-reported outcome. We hypothesize that intramuscular pressure (IMP) will be lower in the TUF cohort compared to controls. In addition, we expect that the expert panel consensus likelihood of ACS, defined as the median of the ratings of the individual panel members who evaluated each patient, and the incidence of fasciotomy will be lower in the TUF cohort. Finally, patients in the TUF cohort will demonstrate superior functional outcome at 6 months following injury compared to those in the control cohort, levels of specific biomarkers as measured in the interstitial fluid will be worse in patients with ACS compared to patients without ACS in the treatment group, and there will be a threshold for each biomarker which is predictive of ACS (biomarkers will be collected from at least 10 patients/ up to full sample of intervention arm patients enrolled at Hennepin Healthcare only).