NCT06222866 Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions
| NCT ID | NCT06222866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University Innsbruck |
| Condition | Heart Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-06-25 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients that are known to be pregnant * Known participation in other interventional clinical trial
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06222866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06222866 currently recruiting?
Yes, NCT06222866 is actively recruiting participants. Contact the research team at sasa.rajsic@tirol-kliniken.at for enrollment information.
Where is the NCT06222866 trial being conducted?
This trial is being conducted at Innsbruck, Austria.
Who is sponsoring the NCT06222866 clinical trial?
NCT06222866 is sponsored by Medical University Innsbruck. The trial plans to enroll 400 participants.