Actively Recruiting

Age: 18Years +
All Genders
ID05139589

The ENDOCARDITIS AUMC Data Collection : a Matched Cohort Study on Perioperative Coagulation in Conservatively and Surgically Treated Patients With Valvular Dysfunction, With and Without Infective Endocarditis

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-07-25

3000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare patients with and without infective endocarditis who undergo valve surgery, as well as to evaluate patients with endocarditis treated either surgically or conservatively. The study focuses on understanding factors that may impact the care of these high-risk patients, including coagulation abnormalities, bleeding, and related complications. It will analyze how different pathogens influence disease severity and outcomes such as mortality and thromboembolic events. The study involves observing three groups: patients with infective endocarditis undergoing valve surgery, those with infective endocarditis not requiring surgery, and patients undergoing valve surgery without endocarditis. Researchers will monitor coagulation factors, transfusion needs, heparin resistance, bleeding scores, and use predictive scores related to endocarditis and vasopressor-inotrope use. Comparisons will be made across these groups to better understand perioperative complications. Participants will be followed for up to one year to assess thromboembolic complications and mortality at 30 and 90 days, and one year after surgery or treatment. The study will collect data related to coagulation abnormalities during the first 24 hours after surgery and track pathogens and disease severity for up to 30 days. This detailed monitoring aims to optimize perioperative care for patients with infective endocarditis and valve disease.

CONDITIONS

Brief Title

The ENDOCARDITIS AUMC Data Collection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old
  • Dutch or English speaking
  • All patients with infective endocarditis admitted to Amsterdam UMC during the study period
  • Patients with infective endocarditis scheduled for cardiac valve surgery compared to matched patients scheduled for similar surgery due to non-infectious reasons
Not Eligible

You will not qualify if you...

  • Previous history of coagulation disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 30 days

Participants undergo assessments related to their infective endocarditis status and valve disease before any treatment or observation.

1 to 2 visits depending on clinical status

Monitoring

Duration - Up to 1 year

Participants who undergo routine care are observed for perioperative coagulation abnormalities, transfusion requirements, bleeding scores, and complications including thromboembolic events and mortality.

Follow-up visits at 30 days, 90 days, and 1 year

Trial Site Locations

Total: 1 location

1

Academic Medical Center

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

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Research Team

J

Jennifer S Breel, MPA,MSc

H

Henning Hermanns, MD,PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Clinical presentation, etiology, and outcome of infective endocarditis in the 21st century: the International Collaboration on Endocarditis-Prospective Cohort Study.

David R Murdoch, G Ralph Corey, Bruno Hoen...

https://pubmed.ncbi.nlm.nih.gov/19273776

Trends in infective endocarditis incidence, microbiology, and valve replacement in the United States from 2000 to 2011.

Sadip Pant, Nileshkumar J Patel, Abhishek Deshmukh...

https://pubmed.ncbi.nlm.nih.gov/25975469

Increased blood coagulation and platelet activation in patients with infective endocarditis and embolic events.

N Semnur Buyukasýk, Mehmet Ileri, Aysin Alper...

https://pubmed.ncbi.nlm.nih.gov/15049384

Complete antithrombin replacement for anticoagulation for cardiopulmonary bypass to repair severe infective mitral valve endocarditis.

Soojie Yu, Zain I Khalpey, Raymond K Wong...

https://pubmed.ncbi.nlm.nih.gov/28957943

Effect of infective endocarditis on blood coagulation and platelet activation and comparison of patients with to those without embolic events.

Mehmet Ileri, Aysin Alper, Kubilay Senen...

https://pubmed.ncbi.nlm.nih.gov/12633799