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NCT05889559 · ClinicalTrials.gov registry record · NA
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
A NA study of Tibial Fractures and Acute Compartment Syndrome, sponsored by Major Extremity Trauma Research Consortium.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 4
- Study locations
NCT05889559 is a NA study of Tibial Fractures and Acute Compartment Syndrome that is actively recruiting participants, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 60 participants, below the 335-participant average among 12 other Tibial Fractures trials with a reported enrollment target (82% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT05889559, a NA study of Tibial Fractures and Acute Compartment Syndrome, is actively recruiting participants, sponsored by Major Extremity Trauma Research Consortium.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 4
- Study locations
Study 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. 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.
Conditions Studied
Interventions
- DEVICE Tissue Ultrafiltration Catheters
Study Locations (4)
Maryland
- University of Maryland School of Medicine R Adams Cowley Shock Trauma Center - Baltimore
Minnesota
- Hennepin Healthcare Research Institute - Minneapolis
North Carolina
- Atrium Health Musculoskeletal Institute - Charlotte
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2026-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05889559
The ClinicalTrials.gov registry entry for NCT05889559 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 335-participant average among 12 other Tibial Fractures trials with a reported enrollment target (82% lower). The listed sponsor is Major Extremity Trauma Research Consortium, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Tibial Fractures appearing as the primary indexed condition, and to 1 intervention - of which Tissue Ultrafiltration Catheters is the first listed.
NCT05889559 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Maryland, Minnesota, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05889559 about?
NCT05889559 is a clinical study titled "Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)". 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 intramuscul...
What is the current status of trial NCT05889559?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-01-01. Estimated completion is 2026-07-01.
What conditions does trial NCT05889559 study?
This clinical trial studies the following conditions: Tibial Fractures, Acute Compartment Syndrome, Fracture, Bone.
What interventions are being tested in trial NCT05889559?
The interventions under investigation include: Tissue Ultrafiltration Catheters (DEVICE).
Who is sponsoring clinical trial NCT05889559?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05889559 being conducted?
This trial has 4 study locations across Maryland, Minnesota, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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