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

Primary Purpose

Acute Compartment Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tissue Ultrafiltration Catheters
Sponsored by
Major Extremity Trauma Research Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Compartment Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The target population for this study include adults ages 18-60 with traumatic severe open or closed fractures of the proximal or tibia shaft at risk for ACS by virtue of their mechanism of injury, fracture pattern, or clinical signs. Recruitment of participants will happen during hospital admission for treatment of injury. To be eligible, patients must enroll in the study within 8 hours of injury and meet all of the following criteria: Patients between the ages of 18 and 60 years Patient can be enrolled in the study and study procedures initiated within 8 hours of injury. 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. 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. Exclusion Criteria: 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). 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control Pressure Monitoring Group

    Tissue Ultrafiltration Intervention Group (TUF)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    To test whether TUF reduces the incidence of fasciotomy compared to control patients.
    Proportion of patients with a of fasciotomy
    To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients.
    Proportion of patients with a of Change in continuously measured IMP.
    To test the impact of TUF on improving patient global health
    PROMIS Global Health
    To test the impact of TUF on improving patient physical function
    PROMIS Physical Function

    Full Information

    First Posted
    April 17, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Major Extremity Trauma Research Consortium
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05889559
    Brief Title
    Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
    Official Title
    Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Major Extremity Trauma Research Consortium

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The study will enroll 200 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=100) or to a control group (n=100). 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
    Detailed Description
    The study will enroll 200 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=100) or to a control group (n=100). 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. The study approach hypothesizes that the expert panel consensus likelihood of ACS, defined as the median of the ratings of the individual panel members who evaluated each patient, the incidence of fasciotomy, and intramuscular pressure (IMP) will be lower in the TUF cohort compared to control. In addition, patients in the TUF cohort will demonstrate superior functional outcome and muscle strength 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 10 patients enrolled at Hennepin Healthcare only).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Compartment Syndrome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Pressure Monitoring Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Tissue Ultrafiltration Intervention Group (TUF)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Tissue Ultrafiltration Catheters
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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.
    Description
    The consensus likelihood of ACS as assessed by a panel of experts after review of a standardized patient profile.
    Time Frame
    6 months post injury
    Secondary Outcome Measure Information:
    Title
    To test whether TUF reduces the incidence of fasciotomy compared to control patients.
    Description
    Proportion of patients with a of fasciotomy
    Time Frame
    6 months post injury
    Title
    To test whether TUF reduces Intramuscular Pressure (IMP) compared to control patients.
    Description
    Proportion of patients with a of Change in continuously measured IMP.
    Time Frame
    6 months post injury
    Title
    To test the impact of TUF on improving patient global health
    Description
    PROMIS Global Health
    Time Frame
    6 months post injury
    Title
    To test the impact of TUF on improving patient physical function
    Description
    PROMIS Physical Function
    Time Frame
    6 months post injury

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The target population for this study include adults ages 18-60 with traumatic severe open or closed fractures of the proximal or tibia shaft at risk for ACS by virtue of their mechanism of injury, fracture pattern, or clinical signs. Recruitment of participants will happen during hospital admission for treatment of injury. To be eligible, patients must enroll in the study within 8 hours of injury and meet all of the following criteria: Patients between the ages of 18 and 60 years Patient can be enrolled in the study and study procedures initiated within 8 hours of injury. 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. 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. Exclusion Criteria: 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). 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dana Alkhoury, MPH
    Phone
    (410) 955-7498
    Email
    dalkhou1@jhu.edu

    12. IPD Sharing Statement

    Learn more about this trial

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

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