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Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

NCT06222866 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-11-26

No results posted yet for this study

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

Conditions

  • Heart Surgery
  • Vascular Surgery
  • Delirium
  • Hyperinflammatory Syndrome

Interventions

DIAGNOSTIC_TEST

Anticoagulation monitoring

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

Sponsors & Collaborators

  • Medical University Innsbruck

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2026-08-01
Completion
2026-12-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06222866 on ClinicalTrials.gov