Coronary Artery DiseaseNCT03622671
Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting
A study testing Skeletonized LIMA and Pedicled LIMA in people with Coronary Artery Disease and Internal Mammary-Coronary Artery Anastomosis, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Internal Mammary-Coronary Artery Anastomosis, Coronary Artery Bypass
- What is being tested?
- Skeletonized LIMA and Pedicled LIMA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePoland
- Study dates
- 26 Sep 2018to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
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- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
The John Paul II Hospital
Krakow, Lesser Poland Voivodeship, 31-202
About this study
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
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
- Being tested
- Skeletonized LIMA, Pedicled LIMA
- Keywords
- Coronary Artery By-pass Grafting, CABG, Fibrin, Clot Lysis Time, CLT, Bleeding, Drainage, Rethoracotomy
- Medical subject headings
- Coronary Artery Disease, Postoperative Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletonized LIMAProcedure or surgery
Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
Pedicled LIMAProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Skeletonized LIMA | Active comparator | In patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG. Receives: Procedure: Skeletonized LIMA |
| Pedicled LIMA | Active comparator | In patients in this arm the left internal mammary artery will be harvested as a pedicled graft with wide opening of left pleural cavity. Receives: Procedure: Pedicled LIMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative chest-tube output after 12 hours
Drainage volume after 12 hours
Measured: 12 hours from the end of operation
Secondary outcomes (1)
Perioperative myocardial infarction
Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively
Measured: 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start26 Sep 2018
- Primary completion24 Dec 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with parallel group design. Equal allocation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Mazur, Jagiellonian University
- Investigators
- Piotr Mazur, MD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622671
- Sponsor's protocol ID
- K/ZDS/007961
- Status last verified
- Feb 2020
- First submitted
- 3 Aug 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03622671
- Acronym / sponsor ID
- K/ZDS/007961
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with parallel group design. Equal allocation.
| Arm | Type | Receives |
|---|---|---|
| Skeletonized LIMA | Active comparator | Procedure: Skeletonized LIMAIn patients in this arm the left internal mammary artery will be skeletonized without opening of the left pleural cavity during CABG. |
| Pedicled LIMA | Active comparator | Procedure: Pedicled LIMAIn patients in this arm the left internal mammary artery will be harvested as a pedicled graft with wide opening of left pleural cavity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skeletonized LIMAStandard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura | Procedure or surgery | Skeletonized LIMA |
| Pedicled LIMAStandard CABG - no different form any other procedure of this type except LIMA will be taken down as a pedicled graft with opening the pleura | Procedure or surgery | Pedicled LIMA |
Primary outcome
Postoperative chest-tube output after 12 hours
Time frame: 12 hours from the end of operation
Drainage volume after 12 hours
1 secondary outcome
Perioperative myocardial infarction
Time frame: 48 hours after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Mazur, MD principal investigator
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skeletonized LIMA and Pedicled LIMA in people with Coronary Artery Disease and Internal Mammary-Coronary Artery Anastomosis, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative chest-tube output after 12 hours (time frame: 12 hours from the end of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.