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

February 11, 2020 updated by: Piotr Mazur, Jagiellonian University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolskie
      • Kraków, Malopolskie, Poland, 31-202
        • The John Paul II Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Skeletonized LIMA
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
Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
Active Comparator: Pedicled LIMA
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Principal Investigator: Piotr Mazur, MD, Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2018

Primary Completion (Actual)

December 24, 2019

Study Completion (Actual)

February 10, 2020

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K/ZDS/007961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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