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

Acute Compartment Syndrome Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

The study will enroll 200 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=100) or to a control group (n=100). 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

Clinical Trial Description

The study will enroll 200 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=100) or to a control group (n=100). 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.

The study approach hypothesizes that the expert panel consensus likelihood of ACS, defined as the median of the ratings of the individual panel members who evaluated each patient, the incidence of fasciotomy, and intramuscular pressure (IMP) will be lower in the TUF cohort compared to control. In addition, patients in the TUF cohort will demonstrate superior functional outcome and muscle strength 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 10 patients enrolled at Hennepin Healthcare only). ;

Related Conditions & MeSH terms

• Acute Compartment Syndrome
• Compartment Syndromes
• Syndrome

• NCT number: NCT05889559
• Study type: Interventional
• Source: Major Extremity Trauma Research Consortium
• Contact: Dana Alkhoury, MPH
• Phone: (410) 955-7498
• Email: dalkhou1@jhu.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: July 1, 2026