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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Will the consensus likelihood of ACS, incidence of fasciotomy, and 6-month functional outcomes be better in the TUF cohort?

Are interstitial fluid biomarkers predictive of ACS?

Researchers will compare patients randomized to TUF catheters (n=30) versus control patients receiving standard-of-care only (n=30) to see if TUF lowers ACS risk and improves recovery.

Participants will:

Be enrolled within 14 hours of injury or prior to high-risk surgery within 48 hours.

Receive continuous anterior compartment pressure monitoring.

Undergo standard-of-care clinical evaluation and treatment.

(TUF arm only) Have three TUF catheters placed in the injured limb to remove interstitial fluid.

Return for a 6-month follow-up to assess complications, healing, muscle function, and patient-reported outcomes.

(Hennepin Healthcare subset) Provide interstitial fluid samples for biomarker analysis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Management of Compartment Syndrome With Ultrafiltration

NCT00022815

Compartment Syndrome

COMPLETED PHASE1

Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome

NCT04012723

Compartment Syndrome Traumatic Lower Extremity Compartment Syndrome Traumatic Upper Extremity

COMPLETED NA

Injection Pressure & Adductor Canal Block

NCT02563990

Orthopedic Disorders Injury of Anterior Cruciate Ligament

TERMINATED NA

Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries

NCT00582998

Fracture of Calcaneus, Pilon or Tibial Plateau

COMPLETED NA

French Achilles Tendon Surgery Cohort Study

NCT07338110

Achilles Injuries Tendon Surgery

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will enroll 60 adults ages 18-60 admitted to the hospital with severe open or closed fractures of the proximal tibia or tibial shaft at risk for ACS. Participants will be randomized to either treatment with tissue ultrafiltration (TUF) catheters (n=30) or to a control group (n=30). Patients will be enrolled within 14 hours of initial injury, or just prior to undergoing surgical procedures that are associated with a risk of post-operative ACS within 48 hours of injury. All patients will receive continuous pressure monitoring of the anterior compartment of their leg. Both groups will receive comprehensive clinical evaluation and 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, patients randomized to the experimental arm will have three TUF catheters placed in the anterior muscle compartment of the injured limb. The TUF catheters will be connected to a closed suction drain and will remove interstitial fluid from the muscle. All patients will be followed at 6 months following initial hospital discharge. This visit will include a clinical evaluation of complications, hospital admission and emergency room visits, wound and fracture healing, infection, muscle sensory and function exam and patient-reported outcome.

We hypothesize that intramuscular pressure (IMP) will be lower in the TUF cohort compared to controls. In addition, we expect that the expert panel consensus likelihood of ACS, defined as the median of the ratings of the individual panel members who evaluated each patient, and the incidence of fasciotomy will be lower in the TUF cohort. 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 specific biomarkers as measured in the interstitial fluid will be worse in patients with ACS compared to patients without ACS in the treatment group, and there will be a threshold for each biomarker which is predictive of ACS (biomarkers will be collected from at least 10 patients/ up to full sample of intervention arm patients enrolled at Hennepin Healthcare only).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Compartment Syndrome Fracture, Bone Tibial Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Pressure Monitoring Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Tissue Ultrafiltration Intervention Group (TUF)

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 Type EXPERIMENTAL

Tissue Ultrafiltration Catheters

Intervention Type DEVICE

patients randomized to the experimental arm will have three TUF catheters placed in the anterior muscle compartment of the injured limb. The TUF catheters will be connected to a closed suction drain and will remove interstitial fluid from the muscle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tissue Ultrafiltration Catheters

patients randomized to the experimental arm will have three TUF catheters placed in the anterior muscle compartment of the injured limb. The TUF catheters will be connected to a closed suction drain and will remove interstitial fluid from the muscle.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Eligible patients must meet all of the following criteria and be enrolled during one of two possible times: within 14 hours of injury, or prior to undergoing surgical intervention (internal or external fixation on the injured limb) within 48 hours of admission. Eligible patients will be:

1. Between the ages of 18 and 60 years
2. 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; Schatzker IV medial knee fracture-dislocation; proximal leg injury due to shotgun, rifle, or other projectile, or severe crushing injury.
3. 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 fixation) within 48 hours of admission.
4. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No