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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 is a NA study that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 194 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01561261
The ClinicalTrials.gov registry entry for NCT01561261 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Major Extremity Trauma Research Consortium, which has 30 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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