The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients (NIRS)
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|ClinicalTrials.gov Identifier: NCT01547013|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : October 16, 2017
|Condition or disease|
|Anterior Tibial Compartment Syndrome|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Phase II The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Trauma Patients|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||May 2018|
Critical Controls: Twenty five (25) critically injured subjects with NO "severe" traumatic lower extremity traumatic injuries to provide control data for critically injured physiological status, a state which may induce systemic, vs. regional hypoperfusion. ("Critical" CONTROLS)
Ninety five (95) total (35 Cohort 2A; 35 Cohort 2B; 25 Cohort 2C) subjects with "severe leg injuries" presenting to a participating level 1 trauma center within 12 hours of their injury, to provide data on the acute post-injury phase. (STUDY COHORT)
Subjects meeting COHORT 2 inclusion criteria, who have UNILATERAL "severe leg injuries". Unilateral injuries include patients who meet the inclusion criteria for a "severe lower extremity injury" for ONE lower extremity, with no more than a simple soft tissue injury (eg, simple laceration) on the contralateral leg.
Subjects meeting COHORT 2 inclusion criteria, who have BILATERAL lower extremity injuries, with at least one being a "severe leg injury". Bilateral injury patients include patients with at least one lower extremity injury classified as "severe" based on Cohort 2 inclusion criteria, with a contralateral injury greater than a simple soft tissue injury, including femur, foot, and crush injuries. Note that it is not necessary for both lower extremity injuries to meet the inclusion criteria to be enrolled in this cohort.
Subjects meeting COHORT 2 inclusion criteria, clinically diagnosed by the treating provider using that treating provider's standards of diagnosing ACS, and in addition to being diagnosed with ACS, the subject undergoes four-compartment leg fasciotomy. data collection to start BEFORE fasciotomy and continue AFTER fasciotomy.
- ACS [ Time Frame: 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547013
|United States, Georgia|
|Athens Regional Medical Center|
|Athens, Georgia, United States, 30606|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Atlanta Medical Center|
|Atlanta, Georgia, United States, 30312|
|Principal Investigator:||Brett Freedman, MD||US Army Landstuhl Regional Medical Center|