Acute Compartment SyndromeNCT05889559
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
A study testing Tissue Ultrafiltration Catheters in people with Acute Compartment Syndrome and Fracture, Bone, run by Major Extremity Trauma Research Consortium at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Compartment Syndrome, Fracture, Bone, Tibial Fractures
- What is being tested?
- Tissue Ultrafiltration Catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
University of Maryland School of Medicine R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
- Recruiting
Atrium Health Musculoskeletal Institute
Charlotte, North Carolina, 28207
- Recruiting
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415-1623
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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:
Read more
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.
Read the detailed description
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
- Acute Compartment Syndrome, Fracture, Bone, Tibial Fractures
- Being tested
- Tissue Ultrafiltration Catheters
- Medical subject headings
- Fractures, Bone, Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Ultrafiltration CathetersDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Pressure Monitoring Group | No 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. |
| Tissue Ultrafiltration Intervention Group (TUF) | Experimental | 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. Receives: Device: Tissue Ultrafiltration Catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients.
Proportion of patients with a of Change in continuously measured IMP.
Measured: 6 months post injury
Secondary outcomes (4)
To test whether there are differences in the incidence of ACS in patients with severe leg injuries treated with active TUF compared to the control group.
The consensus likelihood of ACS as assessed by a panel of experts after review of a standardized patient profile.
Measured: 6 months post injury
To test whether TUF reduces the incidence of fasciotomy compared to control patients.
Proportion of patients with a fasciotomy.
Measured: 6 months post injury
To test the impact of TUF on improving patient Global Health
Veteran Rand 12 Health Survey (VR12)
Measured: 6 months post injury
To test the impact of TUF on improving patient physical function
PROMIS Physical Function
Measured: 6 months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Compartment SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889559
- Sponsor's protocol ID
- IRB00268346
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- IRB00268346
- Conditions
- Acute Compartment Syndrome, Fracture, Bone, Tibial Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Pressure Monitoring Group | No 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. |
| Tissue Ultrafiltration Intervention Group (TUF) | Experimental | Device: Tissue Ultrafiltration CathetersParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Ultrafiltration Catheterspatients 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. | Device | Tissue Ultrafiltration Intervention Group (TUF) |
Primary outcome
To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients.
Time frame: 6 months post injury
Proportion of patients with a of Change in continuously measured IMP.
4 secondary outcomes
To test whether there are differences in the incidence of ACS in patients with severe leg injuries treated with active TUF compared to the control group.
Time frame: 6 months post injury
To test whether TUF reduces the incidence of fasciotomy compared to control patients.
Time frame: 6 months post injury
To test the impact of TUF on improving patient Global Health
Time frame: 6 months post injury
To test the impact of TUF on improving patient physical function
Time frame: 6 months post injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Ultrafiltration Catheters in people with Acute Compartment Syndrome and Fracture, Bone, run by Major Extremity Trauma Research Consortium at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Alkhoury, MPH ((410) 955-7498, dalkhou1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients. (time frame: 6 months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.