Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

Sponsor
Medical University Innsbruck
Study ID
NCT06222866
Status
Recruiting
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Conditions

  • Delirium
  • Heart Surgery
  • Hyperinflammatory Syndrome
  • Vascular Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anticoagulation monitoring — DIAGNOSTIC_TEST
    Evaluation of different monitoring modalities to find the most appropriate anticoagulation monitoring tool for UFH therapy

Study Details

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 Dates

First listed
Jan 25, 2024
Start date
Jun 25, 2024
Status verified
Nov 2024
Primary completion
Aug 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Patients after cardiovascular surgery who received anticoagulation
    The investigated population comprises all patients after cardiovascular surgery who received anticoagulation. Subgroup analyses based on the level of inflammation, delirium, anticoagulation, and others will be conducted.

Primary Outcome Measure

Adverse events occurence [ Time Frame: Patient follow-up of maximum 30 days ]

Central Contacts

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