Clinical trial NCT03622671: Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting
Official title: Association of Fibrin Clot Properties With Blood Loss Following Coronary Artery By-pass Grafting - Does Surgical Technique of Left Internal Mammary Artery Harvesting Matter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Internal Mammary-Coronary Artery Anastomosis
Coronary Artery Bypass
Blood Loss, Postoperative
Fibrinolysis
Keywords: Coronary Artery By-pass Grafting
CABG
Fibrin
Clot Lysis Time
CLT
Bleeding
Drainage
Rethoracotomy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial with parallel group design. Equal allocation.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative chest-tube output after 12 hours
timeFrame: 12 hours from the end of operation
Secondary outcomes:
measure: Perioperative myocardial infarction
timeFrame: 48 hours after the procedure
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: The John Paul II Hospital
state: Malopolskie
Study officials:
affiliation: Jagiellonian University
name: Piotr Mazur, MD
role: PRINCIPAL_INVESTIGATOR
References: