Cardiopulmonary BypassPACNCT05033236
Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)
An observational study of Cardiopulmonary Bypass and Inflammatory Response, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Patients undergoing coronary artery bypass graft surgery (CABG) frequently exhibit postoperative bleeding complications which are still a major cause for morbidity and mortality. One major contributing factor is the loss of platelets and impaired platelet function. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiopulmonary Bypass, Inflammatory Response, Platelet Dysfunction
- How many people
- 190 participants
- Where
- 1 siteAustria
- Study dates
- 23 Nov 2018to 30 Jul 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: elective cardiac surgery patients scheduled for CPB procedure meeting the inclusion criteria at the University Hospital Innsbruck
Who may be able to join
- I.1. Male and female subjects > 18 years and < 86 years I.2. elective coronary artery bypass graft surgery with or without valve surgery (max. 2 valves) and elective valve surgery (max. 2 valves) on cardiopulmonary bypass (CPB) I.3. ASA I - IV I.4. written informed consent
Who cannot join
- E.1. emergency CABG with or without cardiac valve surgery and emergency valve surgery and emergency aortic dissection E.2. preexisting complement deficiency syndromes E.3. preexisting thrombocytopathy or thrombocytopenia (platelet count below 100 G/L) E.4. Known history of congenital coagulopathy E.5. Patients that are known to be pregnant E.6 Known participation in another interventional clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergoing coronary artery bypass graft surgery (CABG) frequently exhibit postoperative bleeding complications which are still a major cause for morbidity and mortality. One major contributing factor is the loss of platelets and impaired platelet function. During cardiopulmonary bypass (CPB) blood comes in close contact with foreign surfaces which induces a series of reactions; especially the complement system as part of the innate immunity is highly activated. Due to the strong crosslink between complement system, platelet function and the plasmatic coagulation it is likely that complement activation during CPB has an impact on the overall process of clot formation. Besides the activation of the complement system there is growing evidence that the occurrence of mitochondrial DNA (mtDNA) during CPB might be related to further platelet activation . Activated platelets may enhance micro-thrombosis leading to organ failure and thereby contributing to postoperative morbidity.
One major complication during and after CABG surgery is bleeding requiring transfusion and even reoperation in about 2%- 8% of patients.
Read more
As bleeding complications increase patient morbidity and mortality, this study is designed to investigate the possible mechanisms of platelet loss during CABG.
The hypothesis is that increased complement activation during CPB leads to platelet activation and loss of platelets. Further the degree of complement activation and levels of mtDNA might correlate with postoperative bleeding, transfusion requirements and clinical outcome.
Read the detailed description
2.1. Primary Study Objective The aim of the study is to examine the correlation between complement activation (c5b-9) and platelet decline during elective coronary artery bypass graft (CABG) on cardiopulmonary bypass (CPB).
2.2. Further Study Objectives A secondary aim of the study is to investigate the specific pathway of complement activation, the mtDNA levels and the interaction with platelet function.
Therefore correlations between levels of complement factors [c5b-9, C1q (C1r/C1s), C3a, C5a, MBL, Factor B, Factor D], mtDNA level [human NADH dehydrogenase 1 gene] and platelet function [MPV/PTC ratio and FACS for platelet activation factor 4 (PFA)] will be examined.
Further it will be explored whether the level of complement activation and levels of mtDNA and the plasmatic coagulation system correlate with transfusion requirements, postoperative morbidity (need for revision surgery, cardiovascular events including thromboembolic events, sepsis, single or multiple organ failure according to SOFA Score), and in hospital mortality.
There will be also a correlation conducted between levels of complement [see above] and concentration of coagulation factors [F I - F XIII, FXa, FXIIa, Kallikrein, Bradykinin, endogenous thrombin potential (ETP)], transfusion requirements, mtDNA and platelet function to postoperative morbidity (need for revision surgery, cardiovascular events including thromboembolic events, sepsis, single or multiple organ failure according to SOFA Score) and in hospital mortality.
- Keywords
- bleeding, transfusion, cardiopulmonary bypass, cardiac surgery, complement system
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between complement activation (c5b-9) and platelet decline
The aim of the study is to examine the correlation between complement activation (c5b-9) and platelet decline during elective coronary artery bypass graft (CABG) with or without valve surgery (max. 2 valves) and elective valve surgery (max. 2 valves) on cardiopulmonary bypass (CPB).
Measured: 4 days
Secondary outcomes (1)
A secondary aim of the study is to investigate the specific pathway of complement activation, the mtDNA levels and the interaction with platelet function.
Therefore we search for correlations between levels of complement factors [c5b-9, C1q (C1r/C1s), C3a, C5a, MBL, Factor B, Factor D], mtDNA level [human NADH dehydrogenase 1 gene] and platelet function [MPV/PTC ratio and FACS for platelet activation factor 4 (PFA)].
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start23 Nov 2018
- Primary completion30 Jun 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Martini, MD, Prof., Principal investigator, Medical University Innsbruck - Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033236
- Sponsor's protocol ID
- 1097/2018
- Acronym
- PAC
- Status last verified
- Sep 2022
- First submitted
- 10 Jun 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)
- ClinicalTrials.gov ID
- NCT05033236
- Acronym / sponsor ID
- PAC / 1097/2018
- Keywords
- bleeding, transfusion, cardiopulmonary bypass, cardiac surgery, complement system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 23 Nov 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 2 Sep 2021 (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.
Patients undergoing coronary artery bypass graft surgery (CABG) frequently exhibit postoperative bleeding complications which are still a major cause for morbidity and mortality. One major contributing factor is the loss of platelets and impaired platelet function. During cardiopulmonary bypass (CPB) blood comes in close contact with foreign surfaces which induces a series of reactions; especially the complement system as part of the innate immunity is highly activated. Due to the strong crosslink between complement system, platelet function and the plasmatic coagulation it is likely that complement activation during CPB has an impact on the overall process of clot formation. Besides the activation of the complement system there is growing evidence that the occurrence of mitochondrial DNA (mtDNA) during CPB might be related to further platelet activation . Activated platelets may enhance micro-thrombosis leading to organ failure and thereby contributing to postoperative morbidity.
One major complication during and after CABG surgery is bleeding requiring transfusion and even reoperation in about 2%- 8% of patients.
As bleeding complications increase patient morbidity and mortality, this study is designed to investigate the possible mechanisms of platelet loss during CABG.
The hypothesis is that increased complement activation during CPB leads to platelet activation and loss of platelets. Further the degree of complement activation and levels of mtDNA might correlate with postoperative bleeding, transfusion requirements and clinical outcome.
Detailed description
2.1. Primary Study Objective The aim of the study is to examine the correlation between complement activation (c5b-9) and platelet decline during elective coronary artery bypass graft (CABG) on cardiopulmonary bypass (CPB).
2.2. Further Study Objectives A secondary aim of the study is to investigate the specific pathway of complement activation, the mtDNA levels and the interaction with platelet function.
Therefore correlations between levels of complement factors [c5b-9, C1q (C1r/C1s), C3a, C5a, MBL, Factor B, Factor D], mtDNA level [human NADH dehydrogenase 1 gene] and platelet function [MPV/PTC ratio and FACS for platelet activation factor 4 (PFA)] will be examined.
Further it will be explored whether the level of complement activation and levels of mtDNA and the plasmatic coagulation system correlate with transfusion requirements, postoperative morbidity (need for revision surgery, cardiovascular events including thromboembolic events, sepsis, single or multiple organ failure according to SOFA Score), and in hospital mortality.
There will be also a correlation conducted between levels of complement [see above] and concentration of coagulation factors [F I - F XIII, FXa, FXIIa, Kallikrein, Bradykinin, endogenous thrombin potential (ETP)], transfusion requirements, mtDNA and platelet function to postoperative morbidity (need for revision surgery, cardiovascular events including thromboembolic events, sepsis, single or multiple organ failure according to SOFA Score) and in hospital mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- elective cardiac surgery patients scheduled for CPB procedure meeting the inclusion criteria at the University Hospital Innsbruck
Key inclusion criteria (1 listed)
- I.1. Male and female subjects > 18 years and < 86 years I.2. elective coronary artery bypass graft surgery with or without valve surgery (max. 2 valves) and elective valve surgery (max. 2 valves) on cardiopulmonary bypass (CPB) I.3. ASA I - IV I.4. written informed consent
Key exclusion criteria (1 listed)
- E.1. emergency CABG with or without cardiac valve surgery and emergency valve surgery and emergency aortic dissection E.2. preexisting complement deficiency syndromes E.3. preexisting thrombocytopathy or thrombocytopenia (platelet count below 100 G/L) E.4. Known history of congenital coagulopathy E.5. Patients that are known to be pregnant E.6 Known participation in another interventional clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between complement activation (c5b-9) and platelet decline
Time frame: 4 days
The aim of the study is to examine the correlation between complement activation (c5b-9) and platelet decline during elective coronary artery bypass graft (CABG) with or without valve surgery (max. 2 valves) and elective valve surgery (max. 2 valves) on cardiopulmonary bypass (CPB).
1 secondary outcome
A secondary aim of the study is to investigate the specific pathway of complement activation, the mtDNA levels and the interaction with platelet function.
Time frame: 4 days
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 4 Oct 2022.
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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.
Judith Martini, MD, Prof. principal investigator
Medical University Innsbruck - Anesthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass and Inflammatory Response, run by Medical University Innsbruck at 1 site in Austria.
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 1 inclusion and 1 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 4 Oct 2022. 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 Austria. 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?
correlation between complement activation (c5b-9) and platelet decline (time frame: 4 days). 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 4 Oct 2022.