Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University Innsbruck

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patients that are known to be pregnant

Known participation in other interventional clinical trial

Trial population

All patients needing cardiac or vascular surgery who receive anticoagulation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Anticoagulation monitoring

    Diagnostic test

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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Patients after cardiovascular surgery who received anticoagulation1 intervention

Trial outcomes

Primary outcomes

1

Adverse events occurence

Occurence of adverse events associated with anticoagulation monitoring and hyperinflammation

Time frame
Patient follow-up of maximum 30 days

Secondary outcomes

1

ACT, aPTT, ROTEM, anti-factor Xa: Specific measured anticoagulation levels associated with adverse events

Correlation and thresholds associated with adverse events

Time frame
Patient follow-up of maximum 30 days
2

Correlation of each anticoagulation monitoring test with another (ACT, aPTT, ROTEM, anti-F-Xa)

Correlation between various tests

Time frame
Patient follow-up of maximum 30 days
3

Incidence of UFH-rebound and the need for protamine application

The rate of UFH-rebound

Time frame
Patient follow-up of maximum 30 days
4

Anticoagulation needs for patients receiving ECMO support and experiencing inflammation

Anticoagulation range for patients with inflammation

Time frame
Patient follow-up of maximum 30 days

Other outcomes

Sponsors and contacts

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