Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting
Primary Purpose
Coronary Artery Disease, Internal Mammary-Coronary Artery Anastomosis, Coronary Artery Bypass
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Skeletonized LIMA
Pedicled LIMA
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Artery Disease focused on measuring Coronary Artery By-pass Grafting, CABG, Fibrin, Clot Lysis Time, CLT, Bleeding, Drainage, Rethoracotomy
Eligibility Criteria
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
Sites / Locations
- The John Paul II Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Skeletonized LIMA
Pedicled LIMA
Arm Description
In patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG.
In patients in this arm the left internal mammary artery will be harvested as a pedicled graft with wide opening of left pleural cavity.
Outcomes
Primary Outcome Measures
Postoperative chest-tube output after 12 hours
Drainage volume after 12 hours
Secondary Outcome Measures
Perioperative myocardial infarction
Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively
Full Information
NCT ID
NCT03622671
First Posted
August 3, 2018
Last Updated
February 11, 2020
Sponsor
Jagiellonian University
1. Study Identification
Unique Protocol Identification Number
NCT03622671
Brief Title
Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
February 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Internal Mammary-Coronary Artery Anastomosis, Coronary Artery Bypass, Blood Loss, Postoperative, Fibrinolysis
Keywords
Coronary Artery By-pass Grafting, CABG, Fibrin, Clot Lysis Time, CLT, Bleeding, Drainage, Rethoracotomy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial with parallel group design. Equal allocation.
Masking
ParticipantOutcomes Assessor
Masking Description
The patient will be blinded to LIMA harvesting technique. The laboratory technicians will be blinded to LIMA harvesting technique.
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skeletonized LIMA
Arm Type
Active Comparator
Arm Description
In patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG.
Arm Title
Pedicled LIMA
Arm Type
Active Comparator
Arm Description
In patients in this arm the left internal mammary artery will be harvested as a pedicled graft with wide opening of left pleural cavity.
Intervention Type
Procedure
Intervention Name(s)
Skeletonized LIMA
Intervention Description
Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
Intervention Type
Procedure
Intervention Name(s)
Pedicled LIMA
Intervention Description
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 Outcome Measure Information:
Title
Postoperative chest-tube output after 12 hours
Description
Drainage volume after 12 hours
Time Frame
12 hours from the end of operation
Secondary Outcome Measure Information:
Title
Perioperative myocardial infarction
Description
Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively
Time Frame
48 hours after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Mazur, MD
Organizational Affiliation
Jagiellonian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The John Paul II Hospital
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-202
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting
We'll reach out to this number within 24 hrs