Tissue Ultrafiltration for Acute Compartment Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether tissue ultrafiltration (TUF) can lower muscle pressure and prevent acute compartment syndrome (ACS) in individuals with severe leg fractures. Researchers aim to determine if TUF catheters can reduce the need for fasciotomy surgery and enhance recovery. Participants will be divided into two groups: one receiving standard care and the other using TUF catheters, to compare effectiveness. This trial suits adults with high-energy upper leg injuries, such as severe tibia fractures, who are receiving hospital treatment soon after the injury. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could improve future treatment options for severe leg injuries.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that tissue ultrafiltration catheters are safe for reducing intramuscular pressure?
Research has shown that tissue ultrafiltration (TUF) catheters are generally safe. A small initial study on similar catheters found they were safe and well-tolerated by patients, with no significant negative side effects reported.
TUF catheters help reduce pressure in muscles, which is crucial for preventing acute compartment syndrome. Although studies have not identified major safety concerns, participants should always be informed and discuss with their doctors before joining a trial.12345Why are researchers excited about this trial?
Researchers are excited about the trial of Tissue Ultrafiltration (TUF) for Acute Compartment Syndrome (ACS) because it offers a novel approach to managing this condition. Unlike the standard treatment, which often involves surgical intervention through fasciotomy, TUF uses a less invasive method with catheters to remove excess fluid and reduce pressure in the affected limb. This method not only aims to relieve symptoms more quickly but also potentially minimizes the need for surgery, which can lead to complications and longer recovery times. If successful, TUF could provide a safer, more efficient alternative to current treatment options for ACS.
What evidence suggests that tissue ultrafiltration catheters are effective for preventing acute compartment syndrome?
Research has shown that tissue ultrafiltration (TUF) catheters might lower the risk of acute compartment syndrome (ACS) by reducing pressure inside muscles. A small initial study found that TUF effectively decreases this pressure, which is crucial for preventing ACS. This trial includes a Tissue Ultrafiltration Intervention Group, where participants will undergo TUF of the anterior compartment of the injured limb. This method uses special tubes to remove excess fluid from the injured area, potentially aiding muscle healing. Early tests also suggest that TUF might improve healing and function in the months following an injury. Although more research is needed, this approach appears promising for managing high-pressure situations in muscles after severe fractures.12356
Are You a Good Fit for This Trial?
Adults aged 18-60 with severe fractures near the knee or shinbone, at risk for Acute Compartment Syndrome (ACS), can join this trial. They must be able to start treatment within 8 hours of injury and consent to participate. Those with minor injuries in other limbs may also qualify.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive continuous anterior compartment pressure monitoring and, if in the TUF group, have TUF catheters placed to remove interstitial fluid.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including clinical evaluation of complications, healing, and patient-reported outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Tissue Ultrafiltration Catheters
Trial Overview
The study tests if Tissue Ultrafiltration Catheters can lower pressure inside muscles and prevent ACS after a severe leg fracture. Half the patients will receive these catheters along with standard care, while the other half will only get standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this group will have pressure monitoring of the anterior compartment of their leg using an indwelling IMP catheter (MY01, MY01 Inc., Montreal, CA). The participants 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, participants in this group will will undergo three TUF of the anterior compartment of the injured limb. Participants will be followed for six months post-injury.
Participants in this group will have pressure monitoring of the anterior compartment of their leg using an indwelling IMP catheter (MY01, MY01 Inc., Montreal, CA). The participants 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. Participants will be followed for six months post-injury.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Major Extremity Trauma Research Consortium
Lead Sponsor
Citations
Study Details | NCT05889559 | Evaluation of the ...
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 ...
Evaluation of the diagnostic and therapeutic value of tissue ...
The goal of this clinical trial is to learn if tissue ultrafiltration (TUF) catheters can reduce intramuscular pressure and prevent acute compartment syndrome ( ...
Compartment syndrome ultrafiltration catheters - PubMed - NIH
This pilot study of CMS catheters demonstrates safety of CMS catheter use. Assay of the ultrafiltrate may provide greater sensitivity to muscle injury.
Evaluation of the Diagnostic and Therapeutic Value of ... - DTIC
This application proposes a randomized clinical trial (RCT) to validate tissue ultrafiltration (TUF) as means of diagnosing and preventing acute compartment ...
Use of tissue ultrafiltration for treatment of compartment ...
This pilot study demonstrates the feasibility of tissue ultrafiltration for reduction of intramuscular pressure in this porcine model.
Acute Compartment Syndrome - StatPearls - NCBI Bookshelf
Acute compartment syndrome occurs when there is increased pressure within a closed osteofascial compartment, resulting in impaired local circulation.
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