Predicting Acute Compartment Syndrome (PACS)

Completed · Not applicable

Conditions studied: Acute Compartment Syndrome

In brief

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).

Key facts

Study ID

NCT01561261

Run by

Major Extremity Trauma Research Consortium

People needed

194

Starts

2012-10-01

Expected to finish

2017-03-01

Last updated by the study team

2018-08-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient between the ages of 18 and 60
• Weight of > 88 lb/40 kg
• Patient presents with one of the following injuries:
• Closed tibial shaft fracture with displacement, comminution, or segmental pattern
• Closed bicondylar tibial plateau fracture or medial tibial plateau-knee dislocation
• Open tibial shaft fracture (Gustilo Type I, II or IIIA)
• Open bicondylar tibial plateau fracture or medial tibial plateau-knee dislocation (Gustilo Type I, II or IIIA)
• Severe soft tissue crush injury to lower leg
• Gun shot injury to leg
• Proximal fibula fracture
• Injury resulted from a high-energy mechanism (e.g. pedestrian struck; fall > 10 ft; MVA/MCA at speed > 30 mph; injury due to shotgun, rifle, or projectile)
• The injury occurs no more than 12 hours prior to initiation of monitoring
• If bilateral leg injuries are present, only the limb that is most severely injured in the judgment of the investigator will be studied
• At least one extremity must be uninjured to serve as a control for muscle oximetry
• Patients may have other injuries except as noted below under exclusion criteria
• Patient may have impending compartment syndrome at time of evaluation; however, the surgeon must be able to initiate monitoring and take at least one set of muscle pressures and obtain one set of tissue oxygenation measurements prior to performing fasciotomy

You may not qualify if…

• Soft tissue wounds that will interfere with monitoring (i.e. the insertion of indwelling pressure catheters and/or application of NIRS pads to the anterior and deep posterior compartments of the leg)
• Patients with known peripheral vascular disease
• Informed consent from the patient or from a legally authorized representative (LAR) is not obtained early enough to begin monitoring within 12 hours post-injury
• Non-ambulatory due to an associated complete spinal cord injury
• Non-ambulatory before the injury due to a pre-existing condition
• Patient speaks neither English nor Spanish
• Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
• Prior extensive traumatic injury requiring surgery to either lower extremity.

Where it is running

• Denver Health and Hospital Authority — Denver, Colorado, United States
• University of Maryland/R Adams Cowley Shock Trauma Medical Center — Baltimore, Maryland, United States
• Hennepin County Medical Center / Regions Hospita — Minneapolis, Minnesota, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Vanderbilt Medical Center — Nashville, Tennessee, United States
• San Antonio Military Medical Center — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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