About this trial
The goal of this prospective observational study is to evaluate the most appropriate anticoagulation monitoring tool for unfractionated heparin (UFH), by comparison of different monitoring modalities in relation to adverse events occurrence (thrombosis/bleeding).
The main study questions are:
* What is the most appropriate anticoagulation monitoring tool (ACT, aPTT, viscoelastic tests (ROTEM), and anti-Xa) for UFH * What is the incidence of adverse events associated with anticoagulation and inflammation after heart and vascular interventions * Is there an association of available anticoagulation thresholds and monitoring tests with bleeding and/or thrombosis occurrence * Is there an association of inflammation with delirium
Secondary study objectives include:
* Association of anticoagulation levels as measured by ACT, aPTT, viscoelastic tests (ROTEM), and anti-factor-Xa with adverse events * Correlation of each anticoagulation monitoring test with the UFH anti-Xa measurement * Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa) and the amount of blood loss post surgery * The incidence of UFH-rebound effect and the need for protamine application * Association of inflammation and increased / reduced need for anticoagulation titration * Correlation of anticoagulation dosing with anticoagulation monitoring tests and adverse events * The association of inflammation with adverse events * The association and impact of inflammation on measured levels of anticoagulation with available tests * Influence of anticoagulation on mortality * Incidence of ECMO support * Incidence of delirium (hypoactive and hyperactive) and correlation with vital (newly onset postoperative atrial fibrillation amongst others) and laboratory parameters, including, and pre-existing neurological disorders
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: > 17 years
Informed written consent
Scheduled for cardiac intervention where the use of UFH is expected (elective surgery)
Scheduled for vascular intervention when the need for perioperative anticoagulation is expected (elective surgery)
Disqualifiers
Patients that are known to be pregnant
Known participation in other interventional clinical trial
Trial population
All patients needing cardiac or vascular surgery who receive anticoagulation
Trial design
Cohort
Prospective
Treatments tested in this trial
Anticoagulation monitoring
Diagnostic testEvaluation of different monitoring modalities to find the most appropriate anticoagulation monitoring tool for UFH therapy
Treatment groups
Trial outcomes
Primary outcomes
Adverse events occurence
Occurence of adverse events associated with anticoagulation monitoring and hyperinflammation
Secondary outcomes
ACT, aPTT, ROTEM, anti-factor Xa: Specific measured anticoagulation levels associated with adverse events
Correlation and thresholds associated with adverse events
Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa)
Correlation between various tests
Incidence of UFH-rebound and the need for protamine application
The rate of UFH-rebound
Anticoagulation needs for patients receiving ECMO support and experiencing inflammation
Anticoagulation range for patients with inflammation
Sponsors and contacts
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