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NCT01561261 · ClinicalTrials.gov registry record · NA
Predicting Acute Compartment Syndrome (PACS)
A NA study, sponsored by Major Extremity Trauma Research Consortium.
- Completed
- Registry status
- NA
- Development phase
- 194
- Enrollment target
NCT01561261: Completed NA study, sponsored by Major Extremity Trauma Research Consortium.
NCT01561261 is a NA study that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 194 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01561261, a NA study, has completed, sponsored by Major Extremity Trauma Research Consortium.
- COMPLETED
- Registry status
- NA
- Development phase
- 194 participants
- Enrollment target
Study Summary
The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS). The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring). Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data: * A physiologic "fingerprint" composed of continuous pressure versus time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels). * Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the Short Musculoskeletal Function Assessment (SMFA).
Primary Outcome
Retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data: A physiologic "fingerprint" composed of continuous pressure vs. time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels). Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function us
Interventions
- OTHER Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2012-10 |
| Est. Completion | 2017-03 |
| Phase | NA |
What the finished NCT01561261 record still lists
NCT01561261 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP) is the first listed.
NCT01561261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01561261 about?
NCT01561261 is a clinical study titled "Predicting Acute Compartment Syndrome (PACS)". The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS). The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (...
What is the current status of trial NCT01561261?
This trial is currently completed. It is a NA study. The enrollment target is 194 participants. The study started on 2012-10. Estimated completion is 2017-03.
What interventions are being tested in trial NCT01561261?
The interventions under investigation include: Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP) (OTHER).
Who is sponsoring clinical trial NCT01561261?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01561261's enrollment target sits among peer trials
194 568th of 2000 higher than 1,432 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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