An observational study in Endocarditis, Coagulation Disorder and Valve Disease, Heart, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
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.
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with infective endocardits requiring valve surgery
Other: None, observational
Patients with infective endocardits, not requiring valve surgery
Other: None, observational
Patients requiring valve surgery
Other: None, observational
Patients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery
Thromboembolic complications
Any thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)
Time frame: up to 1 year
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 surgery
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 days
Plan to share: Undecided
Start is estimated for Aug 2023; primary completion for Dec 2030, 88 months later.
Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's planned 88 months is above that.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) →