A Pilot Study to Evaluate the Systemic Inflammatory Respo... | NCT00739557

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

NCT00739557

Sponsor

The University of Texas Health Science Center, Houston

Status

Withdrawn

Last Update Posted

Dec 7, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Aortic Aneurysm, Thoracic
Systemic Inflammatory Response Syndrome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator left the institution, another PI has not been named.

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Aug 19, 2008

First Submission Date that Met QC Criteria

Aug 20, 2008

First Posted Date

Aug 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2015

Last Update Posted Date

Dec 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to evaluate the effects of TAAAA repair on pro-inflammatory mediators and the anti-inflammatory mediators IL-1 receptor antagonist and IL-10.		30 days

Secondary Outcomes

Measure	Description	Time Frame
To characterize the inflammatory response after TAAA repair and delineate any association to post-operative morbidity		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective TAAA repair

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients entering the hospital for elective TAAA repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth S Helmer, MD	Univ. of Texas Health Science Center at Houston	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017545	Aortic Aneurysm, Thoracic
D018746	Systemic Inflammatory Response Syndrome

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided