Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05889559 |
Other study ID # |
IRB00268346 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2024 |
Est. completion date |
July 1, 2026 |
Study information
Verified date |
November 2023 |
Source |
Major Extremity Trauma Research Consortium |
Contact |
Dana Alkhoury, MPH |
Phone |
(410) 955-7498 |
Email |
dalkhou1[@]jhu.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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).