RecruitingNCT06222866

Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions: Prospective Observational Study


Sponsor

Medical University Innsbruck

Enrollment

400 participants

Start Date

Jun 25, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing better ways to monitor blood thinners (anticoagulants) used during and after heart and vascular surgeries or while patients are on a heart-lung bypass machine (ECMO). The goal is to improve the safety and accuracy of anticoagulation monitoring in these high-risk situations. **You may be eligible if...** - You are over 17 years old - You are scheduled for a heart or vascular surgery where blood thinners (unfractionated heparin) will be used - OR you are currently on ECMO (a machine that supports heart and lung function) - You have provided written informed consent **You may NOT be eligible if...** - You are known to be pregnant - You are already participating in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAnticoagulation monitoring

Evaluation of different monitoring modalities to find the most appropriate anticoagulation monitoring tool for UFH therapy


Locations(1)

Medical University Innsbruck

Innsbruck, Tyrol, Austria

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NCT06222866


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