Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery

NCT00481806 | Unknown

• 2 other identifiers: 479R01HL084080-01A1
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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

Keywords

Virchow's Triad; Thrombin; Graft Failure

Outcome Measures

Primary Outcomes (4)

• Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation

  Measured at 5 years

• Pressure distention is the main stimulus that creates a loss of thrombin control within the SVG

  Measured at 5 years

• Accurate tests of graft quality will be developed that provide rapid results for ready translation into clinical applications

  Measured at 5 years

• Aprotinin or bivalirudin will effectively suppress thrombin generation and its effects within the highest risk grafts

  Measured at 5 years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients between the the age of 18-90 years belonging to all races will be enrolled in the study

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead
• University of Maryland, Baltimore County: collaborator

Study Sites (1)

University of Arizona College of Medicine

Tucson, Arizona, 85724, United States

RECRUITING

Related Publications (2)

• Desai P, Kiani S, Thiruvanthan N, Henkin S, Kurian D, Ziu P, Brown A, Patel N, Poston R. Impact of the learning curve for endoscopic vein harvest on conduit quality and early graft patency. Ann Thorac Surg. 2011 May;91(5):1385-91; discussion 1391-2. doi: 10.1016/j.athoracsur.2011.01.079.

  PMID: 21524447 DERIVED

• Poston RS, Tran R, Collins M, Reynolds M, Connerney I, Reicher B, Zimrin D, Griffith BP, Bartlett ST. Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques. Ann Surg. 2008 Oct;248(4):638-46. doi: 10.1097/SLA.0b013e31818a15b5.

  PMID: 18936577 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and vein samples

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert S. Poston, MD

  University of Arizona, Tucson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert S. Poston, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Cardiothoracic Surgery

Study Record Dates

• First Submitted: May 31, 2007
• First Posted: June 4, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 10, 2013

Record last verified: 2013-05

Locations

US (1)