Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting
NCT ID: NCT03622671
Last Updated: 2020-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2018-09-26
2020-02-10
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Skeletonized LIMA
In patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG.
Skeletonized LIMA
Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Jagiellonian University
OTHER
Responsible Party
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Piotr Mazur
Principal Investigator
Principal Investigators
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Piotr Mazur, MD
Role: PRINCIPAL_INVESTIGATOR
Jagiellonian University
Locations
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The John Paul II Hospital
Krakow, Lesser Poland Voivodeship, Poland
Countries
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Other Identifiers
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K/ZDS/007961
Identifier Type: -
Identifier Source: org_study_id
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