Tissue Ultrafiltration for Acute Compartment Syndrome

Recruiting at 3 trial locations

Overseen By Dana Alkhoury, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Major Extremity Trauma Research Consortium

Disqualifiers: Peripheral vascular disease, Spinal cord injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Hospital stay (up to 48 hours post-injury)

60 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 5 6}

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

Patient can be enrolled in the study and study procedures initiated within 8 hours of injury.

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).

Patient (or authorized legal representative) willing to sign informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

14-48 hours

1 visit (in-person)

Treatment

Participants receive continuous anterior compartment pressure monitoring and, if in the TUF group, have TUF catheters placed to remove interstitial fluid.

Hospital stay (up to 48 hours post-injury)

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical evaluation of complications, healing, and patient-reported outcomes.

6 months

1 visit (in-person) at 6 months

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?

Group I: Tissue Ultrafiltration Intervention Group (TUF) Experimental Treatment 1 Intervention

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.

Group II: Control Pressure Monitoring Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Major Extremity Trauma Research Consortium

Lead Sponsor

Trials

32

Recruited

27,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05889559

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 ...

2. hopkinsmedicine.org hopkinsmedicine.org/clinical-trials/results/irb00268346

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 ( ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21577072/

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.

4. apps.dtic.mil apps.dtic.mil/sti/trecms/pdf/AD1162362.pdf

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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15795576/

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.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK448124/

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.