Anticoagulation and Inflammation Monitoring in Patients After Heart and Vascular Interventions

NCT06222866 | Recruiting

• 1 other identifier: PAC-AIM
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Surgery; Vascular Surgery; Delirium; Hyperinflammatory Syndrome

Keywords

cardiac surgery; vascular surgery; Anticoagulation; Adverse Events; Monitoring; Delirium; Inflammation

Outcome Measures

Primary Outcomes (1)

• Adverse events occurence

  Occurence of adverse events associated with anticoagulation monitoring and hyperinflammation

  Patient follow-up of maximum 30 days

Secondary Outcomes (6)

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

  Patient follow-up of maximum 30 days

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

  Patient follow-up of maximum 30 days

• Incidence of UFH-rebound and the need for protamine application

  Patient follow-up of maximum 30 days

• Anticoagulation needs for patients receiving ECMO support and experiencing inflammation

  Patient follow-up of maximum 30 days

• Association of significant inflammation with adverse events

  Patient follow-up of maximum 30 days

Study Arms (1)

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.

Diagnostic Test: Anticoagulation monitoring

Interventions

Anticoagulation monitoring DIAGNOSTIC_TEST

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

Patients after cardiovascular surgery who received anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients needing cardiac or vascular surgery who receive anticoagulation

You may qualify if:

• 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

You may not qualify if:

• Patients that are known to be pregnant
• Known participation in other interventional clinical trial

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Delirium; Inflammation

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Central Study Contacts

Sasa Rajsic, MD, PhD

CONTACT

004367763004447; sasa.rajsic@tirol-kliniken.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 25, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

AU (1)