NCT Number: NCT05139589
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Amsterdam, North Holland, 1105 AZ, Netherlands
Location status: Recruiting
Henning Hermanns, MD, PhD
CONTACT
+31205669111 ext. 62533
Henning Hermanns, MD,PhD
PRINCIPAL_INVESTIGATOR
Jennifer S Breel, MPA,MSc.
CONTACT
Jennifer S Breel, MPA,MSc.
SUB_INVESTIGATOR
Susanne Eberl, MD,PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with infective endocarditis who do and do not undergo valve surgery compared with patientswithout endocarditis, who are operated on with similar valve surgery
Time frame: up to 1 year
Any thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)
Time frame: First 24 hours after surgery
How often perioperative coagulation abnormalities, measured by classical laboratory values and rotational thromboelastometry are seen from diagnosis to 24 hours post-surgery
Time frame: Up to 30 days
To evaluate the effect of different pathogens (evaluated by laboratory results) on the clinical status
Contact information is provided by the study sponsor or research team.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
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
Acronym: ENDO_AUMC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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