- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622671
Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Malopolskie
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Kraków, Malopolskie, Poland, 31-202
- The John Paul II Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
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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.
|
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
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12 hours from the end of operation
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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
Sponsor
Investigators
- Principal Investigator: Piotr Mazur, MD, Jagiellonian University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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