Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)

NCT05033236 | Completed

• 1 other identifier: 1097/2018
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiopulmonary Bypass; Inflammatory Response; Platelet Dysfunction

Keywords

bleeding; transfusion; cardiopulmonary bypass; cardiac surgery; complement system

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  4 days

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

elective cardiac surgery patients scheduled for CPB procedure meeting the inclusion criteria at the University Hospital Innsbruck

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

University Hospital Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith Martini, MD, Prof.

  Medical University Innsbruck - Anesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: September 2, 2021
• Study Start: November 23, 2018
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Locations

AU (1)