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

Study Overview
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Brief Summary
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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.

Official Title
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Association of Fibrin Clot Properties With Blood Loss Following Coronary Artery By-pass Grafting - Does Surgical Technique of Left Internal Mammary Artery Harvesting Matter

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

Intervention / Treatment
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* Procedure: Skeletonized LIMA
* Procedure: Pedicled LIMA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial with parallel group design. Equal allocation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Skeletonized LIMA<br>In patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG. | Procedure: Skeletonized LIMA<br>* Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura<br>|
| Active Comparator: Pedicled LIMA<br>In patients in this arm the left internal mammary artery will be harvested as a pedicled graft with wide opening of left pleural cavity. | Procedure: Pedicled LIMA<br>* Standard CABG - no different form any other procedure of this type except LIMA will be taken down as a pedicled graft with opening the pleura<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative chest-tube output after 12 hours | Drainage volume after 12 hours | 12 hours from the end of operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative myocardial infarction | Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively | 48 hours after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibrin, Coronary Artery By-pass Grafting, CABG, Clot Lysis Time, CLT, Bleeding, Drainage, Rethoracotomy