Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-04-17
Brief Title:
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome ACS
Sponsor:
Major Extremity Trauma Research Consortium
Organization:
Major Extremity Trauma Research Consortium
Study Overview
Official Title:
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome ACS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n100 or to a control group n100 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 n100 or to a control group n100 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None