The ENDOCARDITIS AUMC Data Collection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous history of coagulation disorders
Trial 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).
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
None, observational
Other interventionPatients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery
Treatment groups
3,000 Participants
are divided into 3 treatment groupsGroup A: Infective endocarditis, surgical arm1 intervention
Group B: Infective endocarditis, conservative arm1 intervention
Group C: Valve disease, heart, surgically repaired1 intervention
Trial outcomes
Primary outcomes
1
Thromboembolic complications
Any thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)
Time frame
up to 1 yearSecondary outcomes
1
Incidence of perioperative coagulation abnormalities
How often perioperative coagulation abnormalities, measured by classical laboratory values and rotational thromboelastometry are seen from diagnosis to 24 hours post-surgery
Time frame
First 24 hours after surgery2
Differences in incidence of pathogens and the relation with disease severity
To evaluate the effect of different pathogens (evaluated by laboratory results) on the clinical status
Time frame
Up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov