Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

Recruiting now

Conditions studied: Heart Surgery, Vascular Surgery, Delirium, Hyperinflammatory Syndrome

In brief

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

Key facts

Study ID

NCT06222866

Run by

Medical University Innsbruck

People needed

400

Starts

2024-06-25

Expected to finish

2026-12-01

Last updated by the study team

2024-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• Patients receiving ECMO support

You may not qualify if…

• Patients that are known to be pregnant
• Known participation in other interventional clinical trial

Where it is running

• Medical University Innsbruck — Innsbruck, Tyrol, Austria (enrolling)

Full record on ClinicalTrials.gov

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