Clinical trial NCT05139589: The ENDOCARDITIS AUMC Data Collection
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endocarditis
Coagulation Disorder
Valve Disease, Heart
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of two groups (a study group and a control group) of male and female patients, 18 years and older. The study group consists of all patients with infective endocarditis admitted to the Amsterdam UMC, in either location. Endocarditis patients undergoing valve surgery will also be compared to patients undergoing similar surgery for non-infectious reasons (control group).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thromboembolic complications
timeFrame: up to 1 year
Secondary outcomes:
measure: Incidence of perioperative coagulation abnormalities
timeFrame: First 24 hours after surgery
measure: Differences in incidence of pathogens and the relation with disease severity
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: North Holland
Study officials:
affiliation: Amsterdam Academic Medical Center
name: Markus W Hollmann, MD,PhD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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