Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting

Jagiellonian University

Status: Completed

Conditions: Fibrinolysis; Internal Mammary-Coronary Artery Anastomosis; Coronary Artery Disease; Blood Loss, Postoperative; Coronary Artery Bypass

Treatments: Procedure: Pedicled LIMA; Procedure: Skeletonized LIMA

Study type: Interventional

Funder types: Other

Identifiers

NCT03622671

K/ZDS/007961

Details and patient eligibility

About

Up to 15% of operations in cardio-pulmonary by-pass are complicated by excessive postoperative blood loss, which negatively affects the outcomes. Recently, it has been demonstrated that fibrin clot susceptibility to lysis is a modulator of postoperative blood loss after cardiac surgery for aortic stenosis. Earlier, a preliminary study showed a negative association of postoperative blood loss after coronary artery by-pass grafting (CABG) with fibrin clot lysis time, reflecting susceptibility to fibrinolysis.

In CABG, postoperative blood loss may depend on the operative technique with respect to left internal mammary artery (LIMA) harvesting. LIMA is taken down in virtually all CABG procedures, but harvesting technical details remain at surgeons discretion (skeletonization without opening the pleural cavity vs. pedicled graft with pleura wide open).

The investigators decided to test the hypothesis that fibrin clot properties modulate the postoperative drainage following CABG strongly enough to attenuate the influence of surgical technique by randomizing the patients undergoing CABG with regard to LIMA harvesting technique.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Angiographically confirmed coronary artery disease
• Heart Team qualification for first time elective coronary artery by-pass grafting
• No significant valvular disease or congenital heart disease
• Normal sinus rhythm on ECG
• Continued aspirin in perioperative period

Exclusion criteria

• Need for any concomitant cardiac procedure
• St. p. percutaneous coronary intervention within preceding 3 months
• Any previous cardiac surgery
• Known bleeding diathesis
• Acute cardiovascular incident within preceding 3 months
• Heart failure with left ventricular ejection fraction <30%
• Any autoimmune disease
• Any acute infection
• Known neoplasm
• Any thyroid disease
• Treatment with any thienopyridine, oral anticoagulant, heparin or any non-steroid anti-inflammatory agent other than aspirin
• Mental disorder
• Severe comorbidities (liver failure, renal failure on hemodialysis)
• Lacking consent

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Skeletonized LIMA

Active Comparator group

Description:

In patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG.

Treatment:

Procedure: Skeletonized LIMA

Pedicled LIMA

Active Comparator group

Description:

In patients in this arm the left internal mammary artery will be harvested as a pedicled graft with wide opening of left pleural cavity.

Treatment:

Procedure: Pedicled LIMA