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NCT Number: NCT03622671

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Blood Loss, Postoperative Cardiovascular Diseases Coronary Artery Bypass Coronary Disease Fibrinolysis Heart Diseases Hemorrhage Internal Mammary-Coronary Artery Anastomosis Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The John Paul II Hospital

Krakow, Lesser Poland Voivodeship, 31-202, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skeletonized LIMA

Procedure

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

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

Primary outcomes

  1. Postoperative chest-tube output after 12 hours

    Time frame: 12 hours from the end of operation

    Drainage volume after 12 hours

Secondary outcomes

  1. Perioperative myocardial infarction

    Time frame: 48 hours after the procedure

    Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 9, 2018
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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