Blood Loss, Postoperative, Coronary Artery Bypass, Coronary Artery Disease, Fibrinolysis, Internal Mammary-Coronary Artery Anastomosis
Conditions
Keywords
Coronary Artery By-pass Grafting, CABG, Fibrin, Clot Lysis Time, CLT, Bleeding, Drainage, Rethoracotomy
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.
Interventions
PROCEDURESkeletonized LIMA
Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
PROCEDUREPedicled LIMA
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
Sponsors
Jagiellonian University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient will be blinded to LIMA harvesting technique. The laboratory technicians will be blinded to LIMA harvesting technique.
Intervention model description
Randomized clinical trial with parallel group design. Equal allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative chest-tube output after 12 hours | 12 hours from the end of operation | Drainage volume after 12 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative myocardial infarction | 48 hours after the procedure | Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively |
Countries
Poland
Outcome results
None listed