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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622671
• Other study ID #: K/ZDS/007961
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: February 10, 2020

Study information

• Verified date: February 2020
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 10, 2020
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Skeletonized LIMA
Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
• Pedicled 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

Locations

Country	Name	City	State
Poland	The John Paul II Hospital	Kraków	Malopolskie

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative chest-tube output after 12 hours	Drainage volume after 12 hours	12 hours from the end of operation
Secondary	Perioperative myocardial infarction	Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively	48 hours after the procedure