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A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.

This study has been terminated.
(Investigator left the institution, another PI has not been named.)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00739557
First received: August 19, 2008
Last updated: August 25, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition
Aortic Aneurysm, Thoracic
Systemic Inflammatory Response Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients entering the hospital for elective TAAA repair

Criteria

Inclusion Criteria:

  • Elective TAAA repair

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739557

Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Kenneth S Helmer, MD Univ. of Texas Health Science Center at Houston
  More Information

No publications provided

Responsible Party: Kenneth Helmer, M.D., Univ. of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier: NCT00739557     History of Changes
Other Study ID Numbers: 07-0257
Study First Received: August 19, 2008
Last Updated: August 25, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
elective TAAA repair

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Systemic Inflammatory Response Syndrome
Vascular Diseases
 Cardiovascular Diseases
Aortic Diseases
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on May 16, 2013