Last reviewed · How we verify
NCT05889559
Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)
NA trial testing Tissue Ultrafiltration Catheters in Acute Compartment Syndrome in 60 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | Major Extremity Trauma Research Consortium |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 January 2024 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 July 2026 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Tissue Ultrafiltration Catheters
Conditions studied
- Acute Compartment Syndrome — all drugs for Acute Compartment Syndrome →
- Fracture, Bone — all drugs for Fracture, Bone →
- Tibial Fractures — all drugs for Tibial Fractures →
Sponsor
Major Extremity Trauma Research Consortium
Who can join
Adults 18 to 60, any sex, with Acute Compartment Syndrome or Fracture, Bone. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05889559
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acute Compartment Syndrome
Currently open trials in the same condition.
- NCT05030259 — The Research About the ACS After Femoropopliteal Arterial Injuries · recruiting
- NCT04529330 — The Research About Acute Compartment Syndrome · recruiting
Other Major Extremity Trauma Research Consortium trials
Trials by the same sponsor.
- NCT06337292 — Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures · Phase 3 · recruiting
- NCT04789044 — Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion) · Phase 2 · recruiting
- NCT04839497 — Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of · Phase 2 · recruiting
- NCT05143476 — Serum-Protein-Based Indices for the Progression of Fracture Healing and Nonunion · completed
- NCT04597008 — Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05889559 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Major Extremity Trauma Research Consortium
- Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05889559.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing