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The ENDOCARDITIS AUMC Data Collection (ENDO_AUMC)

A

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Enrolling

Conditions

Coagulation Disorder
Endocarditis
Valve Disease, Heart

Treatments

Other: None, observational

Study type

Observational

Funder types

Other

Identifiers

NCT05139589
W21_466#21.518

Details and patient eligibility

About

The investigators will compare patients with and without infective ndocarditis undergoing valve surgery and evaluate factors that may help optimise perioperative care of these high-risk patients.

Full description

The aim of this study is to examine the differences between patients with and without endocarditis who undergo cardiothoracic (valve) surgery. In addition, the investigators will look at the differences between endocarditis patients who undergo surgery, and those who are treated conservatively. The investigators will look at incidence and degree of perioperative coagulation abnormalities, as well as transfusion and coagulation factor requirements, heparin resistance, bleeding scores, predictive endocarditis mortality scores, vasopressor-inotrope scores, and relate these where possible to the pathogen causing IE. The investigators will also look at perioperative complications, in particular, thromboembolic events and mortality at 30 and 90 days, and at 1 year.

These outcomes may help optimise perioperative care for high-risk endocarditis patients, and in particular those undergoing valve surgery.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients > 18 years
  • Dutch or English speaking
  • All patients with infective endocarditis admitted to Amsterdam UMC in the study period
  • All patients with infective endocarditis scheduled for cardiac valve surgery compared to a matched cohort of patients scheduled for similar surgery due to non-infectious indication in Amsterdam UMC in the same period

Exclusion criteria

  • Previous history of coagulation disorders

Trial design

3,000 participants in 3 patient groups

Infective endocarditis, surgical arm
Description:
Patients with infective endocardits requiring valve surgery
Treatment:
Other: None, observational
Infective endocarditis, conservative arm
Description:
Patients with infective endocardits, not requiring valve surgery
Treatment:
Other: None, observational
Valve disease, heart, surgically repaired
Description:
Patients requiring valve surgery
Treatment:
Other: None, observational

Trial contacts and locations

1

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Central trial contact

Jennifer S Breel, MPA,MSc; Henning Hermanns, MD,PhD

Data sourced from clinicaltrials.gov

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