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

NCT03622671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-02-12

No results posted yet for this study

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

Interventions

PROCEDURE

Skeletonized LIMA

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

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

Sponsors & Collaborators

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Piotr Mazur, MD · Jagiellonian University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2019-12-24
Completion
2020-02-10

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03622671 on ClinicalTrials.gov