A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.
The purpose of this study is to look at the systemic inflammatory response caused when patients undergo thoracoabdominal aortic aneurysm repair (TAAA). In addition, this study will look at how the inflammatory response affects the post operative healing process and post operative complications.
Aortic Aneurysm, Thoracic
Systemic Inflammatory Response Syndrome
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.|
- to evaluate the effects of TAAAA repair on pro-inflammatory mediators and the anti-inflammatory mediators IL-1 receptor antagonist and IL-10. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- To characterize the inflammatory response after TAAA repair and delineate any association to post-operative morbidity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood and saliva samples will be obtained for the purposes of this study and will be maintained until complete analysis of the samples for all patients is complete.
|Study Start Date:||August 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Patients will be invited to participate in this study prior to the TAAA repair procedure. Prior to the surgery, baseline blood and saliva samples will be collected. Following the surgery, blood and saliva samples will be collected for 48 hours. In addition, hemodynamic data (i.e. vital signs) will be collected for the first 48 hours. The patient data will be reviewed for the first 30 days for morbidity and mortality assessment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739557
|Principal Investigator:||Kenneth S Helmer, MD||Univ. of Texas Health Science Center at Houston|