Clinical Trials Logo

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT05033236
Study type Observational [Patient Registry]
Source Medical University Innsbruck
Contact Nicole Innerhofer, MD
Phone +4351250481077
Email nicole.innerhof[email protected]
Status Recruiting
Start date November 23, 2018
Completion date August 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Recruiting NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Not yet recruiting NCT04608643 - Inflammatory Markers and Cbc Indices in Severely Malnourished Children
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Recruiting NCT01417923 - The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain Phase 4
Terminated NCT01377441 - Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia. Phase 4
Completed NCT01301079 - Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia Phase 3
Terminated NCT00578578 - Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels Phase 4
Recruiting NCT04611334 - The Effects of HRV Biofeedback on Chronic Kidney Disease Patient. N/A
Completed NCT03445234 - Blueberries, Bananas, Exercise Recovery N/A
Completed NCT04864600 - CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles N/A
Not yet recruiting NCT04386525 - Omega 3 and Ischemic Stroke; Fish Oil as an Option Phase 4
Completed NCT04014439 - Relationship Between NLR and Prealbumin Levels With Diaphragm Thickness
Recruiting NCT03002259 - Dexamethasone for Cardiac Surgery-II Trial Phase 4
Not yet recruiting NCT03245684 - Assisted or Controlled Ventilation in Ards (Ascovent) N/A
Recruiting NCT04118049 - Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment N/A
Completed NCT03310450 - Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels
Recruiting NCT04078776 - Systemic and White Adipose Tissue Inflammatory Profile in Lean Versus Obese Individuals