BridgeMD
New treatment option for Acute Compartment Syndrome
Official title Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
ClinicalTrials.gov ID: NCT05889559
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- The target population for this study include adults ages 18-60 with high-energy injuries of the upper leg considered at risk for ACS at time of...
- 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...
- Patient can be enrolled in the study and study procedures initiated within 14 hours of injury,\ or be enrolled prior to undergoing urgent surgical...
- Patient (or authorized legal representative) willing to sign informed consent.
You likely can't join if
- ), the patient can be enrolled and the study procedures initiated at the end of surgery. If an eligible patient is enrolled and there is no surgery...
- Patients not willing to participate
- Patients with non-traumatic cases of acute compartment syndrome (e.g. severe exertion, snakebite, high-pressure injection injury)
- Patients diagnosed with ACS or impending ACS such that immediate fasciotomy is recommended
- Soft tissue wounds, including lacerations or abrasions, that are in a location that will interfere with safe insertion of indwelling pressure or TUF...
- Patients not likely to follow-up (are homeless, incarcerated, live out-of-state).
See the full eligibility criteria
- The target population for this study include adults ages 18-60 with high-energy injuries of the upper leg considered at risk for ACS at time of admission by virtue of their mechanism of injury, fracture pattern...
- 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...
- 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...
- Patient (or authorized legal representative) willing to sign informed consent.
- If a patient has an eligible injury and is going to surgery within 2 hours (except for fasciotomy - which is an
- ), the patient can be enrolled and the study procedures initiated at the end of surgery. If an eligible patient is enrolled and there is no surgery anticipated within 2 hours, initiate study procedures immediately...
- Patients not willing to participate
- Patients with non-traumatic cases of acute compartment syndrome (e.g. severe exertion, snakebite, high-pressure injection injury)
- Patients diagnosed with ACS or impending ACS such that immediate fasciotomy is recommended
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
- Charlotte, North Carolina, United States
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Minneapolis, Minnesota, United States; Charlotte, North Carolina, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.