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

Launched by MAJOR EXTREMITY TRAUMA RESEARCH CONSORTIUM · Jun 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method called tissue ultrafiltration (TUF) to see if it can help patients at risk for a condition called Acute Compartment Syndrome (ACS). ACS can happen after severe fractures, particularly in the leg, and involves increased pressure in the muscle compartments, which can lead to serious complications. The trial will include 200 adults, ages 18 to 60, who have recently suffered significant fractures of the proximal tibia (the upper part of the shinbone). To participate, patients must be enrolled within 8 hours of their injury and must meet specific injury criteria.

Participants will be randomly assigned to one of two groups: one group will receive standard care along with the TUF treatment, which involves placing special catheters to help remove excess fluid from the muscle area, while the other group will receive standard care only. Throughout the study, all patients will have their leg monitored closely for any signs of complications, and they will be followed up six months after leaving the hospital to check on their recovery, including how well their wounds and fractures are healing. This trial aims to find out if TUF can improve outcomes for patients at risk of ACS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The target population for this study include adults ages 18-60 with traumatic severe open or closed fractures of the proximal or tibia shaft at risk for ACS by virtue of their mechanism of injury, fracture pattern, or clinical signs. Recruitment of participants will happen during hospital admission for treatment of injury.
• To be eligible, patients must enroll in the study within 8 hours of injury and meet all of the following criteria:
• • 1. Patients between the ages of 18 and 60 years
• • 2. Patient can be enrolled in the study and study procedures initiated within 8 hours of injury.
• • 3. 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.
• • 4. Isolated injury meeting above criteria, except for minor distal extremity injuries (defined as closed injuries distal to wrist and ankle in opposite leg or arms).
• • 5. Patient (or authorized legal representative) willing to sign informed consent.
• Exclusion Criteria:
• * An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Patients not willing to participate
• • 2. Patients with non-traumatic cases of acute compartment syndrome (e.g. severe exertion, snakebite, high-pressure injection injury)
• • 3. Patients diagnosed with ACS or impending ACS such that immediate fasciotomy is recommended
• • 4. 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)
• • 5. Patients not likely to follow-up (are homeless, incarcerated, live out-of-state).
• • 6. Patients with known peripheral vascular disease
• • 7. Non-ambulatory due to an associated complete spinal cord injury; Non-ambulatory before the injury due to a pre-existing condition.
• • 8. Very low clinical concern for ACS at time of admission