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The ENDOCARDITIS AUMC Data Collection

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05139589
Acronym
ENDO_AUMC
Enrollment
3000
Registered
2021-12-01
Start date
2023-08-06
Completion date
2030-12-31
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder, Endocarditis, Valve Disease, Heart

Brief summary

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.

Detailed 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.

Interventions

Patients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery

Sponsors

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

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Thromboembolic complicationsup to 1 yearAny thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)

Secondary

MeasureTime frameDescription
Incidence of perioperative coagulation abnormalitiesFirst 24 hours after surgeryHow often perioperative coagulation abnormalities, measured by classical laboratory values and rotational thromboelastometry are seen from diagnosis to 24 hours post-surgery
Differences in incidence of pathogens and the relation with disease severityUp to 30 daysTo evaluate the effect of different pathogens (evaluated by laboratory results) on the clinical status

Countries

Netherlands

Contacts

Primary ContactJennifer S Breel, MPA,MSc
j.s.breel@amsterdamumc.nl+31610019257
Backup ContactHenning Hermanns, MD,PhD
h.hermanns@amsterdamumc.nl+31205669111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026