Acute Compartment Syndrome Clinical Trial
— PACSOfficial title:
Predicting Acute Compartment Syndrome (PACS) Using Optimized Clinical Assessment, Continuous Pressure Monitoring, and Continuous Tissue Oximetry
NCT number | NCT01561261 |
Other study ID # | 00004105 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | March 2017 |
Verified date | November 2017 |
Source | Major Extremity Trauma Research Consortium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 194 |
Est. completion date | March 2017 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Patient between the ages of 18 and 60 2. Weight of > 88 lb/40 kg 3. 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 4. 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) 5. The injury occurs no more than 12 hours prior to initiation of monitoring 6. If bilateral leg injuries are present, only the limb that is most severely injured in the judgment of the investigator will be studied 7. At least one extremity must be uninjured to serve as a control for muscle oximetry 8. Patients may have other injuries except as noted below under exclusion criteria 9. 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 Exclusion Criteria: 1. 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) 2. Patients with known peripheral vascular disease 3. 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 4. Non-ambulatory due to an associated complete spinal cord injury 5. Non-ambulatory before the injury due to a pre-existing condition 6. Patient speaks neither English nor Spanish 7. 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). 8. Prior extensive traumatic injury requiring surgery to either lower extremity. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland/R Adams Cowley Shock Trauma Medical Center | Baltimore | Maryland |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Denver Health and Hospital Authority | Denver | Colorado |
United States | San Antonio Military Medical Center | Fort Sam Houston | Texas |
United States | Hennepin County Medical Center / Regions Hospita | Minneapolis | Minnesota |
United States | Vanderbilt Medical Center | Nashville | Tennessee |
United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Major Extremity Trauma Research Consortium |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retrospective assessment of the likelihood of compartment syndrome | 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 using the SMFA. |
6 months post index injury | |
Secondary | Clinician agreement in retrospective assessments of the likelihood of ACS. | On the basis of known clinical and functional outcome at 6 months and monitoring information, clinicians will agree on the likelihood of ACS in <90% of cases. | 6 months post index injury |
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