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

NCT03622671 | Completed

• 1 other identifier: K/ZDS/007961
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Postoperative chest-tube output after 12 hours

  Drainage volume after 12 hours

  12 hours from the end of operation

Secondary Outcomes (1)

• Perioperative myocardial infarction

  48 hours after the procedure

Study Arms (2)

Skeletonized LIMA

ACTIVE COMPARATOR

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

Pedicled LIMA

ACTIVE COMPARATOR

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

Interventions

Skeletonized LIMA PROCEDURE

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

Skeletonized LIMA

Pedicled LIMA PROCEDURE

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

Pedicled LIMA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

The John Paul II Hospital

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Postoperative Hemorrhage; Hemorrhage

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Piotr Mazur, MD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded to LIMA harvesting technique. The laboratory technicians will be blinded to LIMA harvesting technique.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial with parallel group design. Equal allocation.

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 9, 2018
• Study Start: September 26, 2018
• Primary Completion: December 24, 2019
• Study Completion: February 10, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

PL (1)