Recruiting

Thrombin

Sponsor:

University of Arizona

Code:

NCT00481806

Conditions

Coronary Artery Bypass

Thrombosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Heart bypass surgery, also known as coronary artery bypass graft (CABG) surgery, creates a detour around the blocked part of a heart artery to restore blood supply to the heart muscle. The saphenous vein, located along the inside of the leg, is commonly used to create the bypass in a CABG surgery. An abnormal increase in the blood clotting protein thrombin may cause the saphenous vein graft to close up and eventually fail. This study will evaluate the relationship between thrombin levels and saphenous vein graft failures in people undergoing a CABG procedure.

Conditions

Coronary Artery Bypass

Thrombosis

Study ID

NCT00481806

Start date

Feb, 2007

Status verified date

May, 2013

Completion date

Dec, 2013

Anticipated

Primary completion date

May, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Scheduled for CABG surgery at University of Arizona University Medical Center (UMC)
  • For females, willing to use a reliable form of birth control for the duration of the study

Exclusion Criteria:

  • Non-dermatologic allergy to intravenous (IV) radiographic contrast
  • Creatinine levels greater than 2.0 mg/dL
  • Pregnant

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation [ Time Frame: Measured at 5 years ]
  • Pressure distention is the main stimulus that creates a loss of thrombin control within the SVG [ Time Frame: Measured at 5 years ]
  • Accurate tests of graft quality will be developed that provide rapid results for ready translation into clinical applications [ Time Frame: Measured at 5 years ]
  • Aprotinin or bivalirudin will effectively suppress thrombin generation and its effects within the highest risk grafts [ Time Frame: Measured at 5 years ]

Central Contacts and Locations

Central contacts

Robert S. Poston, MD

520-626-7951rposton@surgery.arizona.edu

Locations

University of Arizona College of Medicine

Recruiting

Tucson, Arizona, United States, 85724

Principal Investigator:

Robert S. Poston, MD

More Information

Sponsor

University of Arizona

Last update posted

May 10, 2013

Last verified

May, 2013

Keywords

  • Virchow's Triad
  • Thrombin
  • Graft Failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2013-05-10.