Tissue Ultrafiltration for Acute Compartment Syndrome
This study is looking at whether a device called tissue ultrafiltration (TUF) catheters can help prevent acute compartment syndrome (ACS) in adults aged 18-60 who have severe leg fractures. ACS is a serious condition where pressure builds up in the muscles, which can cause damage. Researchers want to see if placing TUF catheters in the injured leg, which remove fluid, can lower this pressure and improve recovery. They will compare 30 patients who receive the TUF catheters to 30 patients who receive standard care. The main goal is to see if TUF reduces muscle pressure and if patients have better outcomes after 6 months. The study is currently recruiting participants.
- Study design
- This is an interventional study that will enroll 60 participants. Participants will be randomly assigned to either receive TUF catheters or standard care.
- What's involved
- If you join, you will be admitted to the hospital with a severe leg fracture. You might have TUF catheters placed in your leg, and your muscle pressure will be continuously monitored. You will also have a follow-up visit 6 months after leaving the hospital.
- Compensation
- Not stated in the trial record.
- Follow-up
- All patients will be followed for 6 months after their initial hospital discharge.
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Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
At a glance
Conditions
Where it's being run
4 sites across 4 statesWho to contact
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What this trial measures
- To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients.6 months post injury
Proportion of patients with a of Change in continuously measured IMP.