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

Not Applicable

Completed

• Conditions: Coronary Artery Bypass; Fibrinolysis; Blood Loss, Postoperative; Coronary Artery Disease; Internal Mammary-Coronary Artery Anastomosis
• Interventions: Procedure: Pedicled LIMA; Procedure: Skeletonized LIMA

• Registration Number: NCT03622671
• Lead Sponsor: Jagiellonian University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Study Start: 2018-09-26
• Primary Completion: 2019-12-24
• Status Verified: 2020-02
• Study Completion: 2020-02-10
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pedicled LIMA	Pedicled LIMA	In patients in this arm the left internal mammary artery will be harvested as a pedicled graft with wide opening of left pleural cavity.
Skeletonized LIMA	Skeletonized LIMA	In patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG.

Primary Outcome Measures

Name	Time	Method
Postoperative chest-tube output after 12 hours	12 hours from the end of operation	Drainage volume after 12 hours

Secondary Outcome Measures

Name	Time	Method
Perioperative myocardial infarction	48 hours after the procedure	Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively

Trial Locations

Locations (1)

The John Paul II Hospital; 🇵🇱 Kraków, Malopolskie, Poland