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NCT Number: NCT06222866

Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location status: Recruiting

Location contact

Axel Kleinsasser, Univ.Doz.Dr.

SUB_INVESTIGATOR

Barbara Sinner, Prof. Dr.

SUB_INVESTIGATOR

Benedikt Treml, Priv.Doz.Dr.

SUB_INVESTIGATOR

Christine Eckhardt, MD, PhD

SUB_INVESTIGATOR

Corinna Velik-Salchner, Priv.Doz.Dr.

SUB_INVESTIGATOR

Nicole Innerhofer, MD

SUB_INVESTIGATOR

Sasa Rajsic, MD, PhD

CONTACT

[email protected]

004367763004447

Sasa Rajsic, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Patients undergoing major heart and vascular surgery are often in need of intraoperative and/or postoperative anticoagulation. To ensure the appropriate blood concentration of anticoagulants and reduce the risk of adverse events, anticoagulation monitoring is crucial. In contrast, due to contact of blood with artificial surfaces, some patients develop hyperinflammation which may increase the risk of thrombosis.

Patients undergoing heart surgery require full heparinization before the start of the heart-lung machine, which is later reversed using protamine. The levels of anticoagulation are intraoperatively monitored with activated clotting time (ACT). In the postoperative period, the monitoring of rest-heparinization or rebound effect is further performed. In certain cases, the addition of protamine is needed, based on the available monitoring tests. The postoperative monitoring of anticoagulation is usually performed using ACT and activated partial thromboplastin time (aPTT), and may be extended by other diagnostic methods, including viscoelastic tests. Moreover, to ensure the hemostatic capacity of the patient, monitoring of other parameters (platelet count, fibrinogen concentration, prothrombin time quick assay (PT), antithrombin level, etc.) may be included. Finally, in the case of patients receiving extracorporeal life support (ECMO), continuous anticoagulation is indicated, and its monitoring is of immense importance.

Furthermore, in the case of vascular surgery, patients require unfractionated heparin (UFH) intraoperatively, including postoperative continuous infusion.

The evidence on correlation and available monitoring tools is scarce and contradictory, usually based on retrospective analyses of patients´ data from medical charts. Additionally, the role of inflammation in the development of delirium is still unclear, and this association is a subject of debate.

Well-known consequences of postoperative delirium (POD) include poor functional outcome with increased morbidity and mortality, and increased healthcare costs due to institutionalization and rehospitalization. The incidence of POD after cardiac and vascular surgery remains between 13 and 52%. The current hypothesis on the pathophysiology of POD includes disruption of the blood-brain barrier allowing peripheral inflammation and mediators to cause neuro-inflammation. Neurotoxicity induced by a disbalance of pro- and anti-inflammatory mediators and oxidative stress might explain neuronal damage and neurotransmitter disbalance responsible for POD. To improve patients´ functional outcome and the financial burden of POD there is a growing interest in identifying predictive and diagnostic (bio-)markers. The neurofilament light chain (NfL) protein has shown promising results as a potential biomarker for POD. However, the literature on cardiac and vascular patients is limited.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anticoagulation monitoring

Diagnostic Test

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

Primary outcomes

  1. Adverse events occurence

    Time frame: Patient follow-up of maximum 30 days

    Occurence of adverse events associated with anticoagulation monitoring and hyperinflammation

Secondary outcomes

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

    Time frame: Patient follow-up of maximum 30 days

    Correlation and thresholds associated with adverse events

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

    Time frame: Patient follow-up of maximum 30 days

    Correlation between various tests

  3. Incidence of UFH-rebound and the need for protamine application

    Time frame: Patient follow-up of maximum 30 days

    The rate of UFH-rebound

  4. Anticoagulation needs for patients receiving ECMO support and experiencing inflammation

    Time frame: Patient follow-up of maximum 30 days

    Anticoagulation range for patients with inflammation

  5. Association of significant inflammation with adverse events

    Time frame: Patient follow-up of maximum 30 days

    Impact of inflammation on adverse events occurence

  6. Incidence of ECMO support and delirium

    Time frame: Patient follow-up of maximum 30 days

    The rate of delirium, and the ECMO rate in patients after cardiovascular surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Sasa Rajsic, MD, PhD

CONTACT

[email protected]

004367763004447

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: PAC-AIM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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