Study on Perioperative Coagulation and Outcomes in Patients With and Without Infective Endocarditis Undergoing Valve Surgery
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-07-25
3000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare patients with and without infective endocarditis who undergo valve surgery, as well as to evaluate patients with endocarditis treated either surgically or conservatively. The study focuses on understanding factors that may impact the care of these high-risk patients, including coagulation abnormalities, bleeding, and related complications. It will analyze how different pathogens influence disease severity and outcomes such as mortality and thromboembolic events.
The study involves observing three groups patients with infective endocarditis undergoing valve surgery, those with infective endocarditis not requiring surgery, and patients undergoing valve surgery without endocarditis. Researchers will monitor coagulation factors, transfusion needs, heparin resistance, bleeding scores, and use predictive scores related to endocarditis and vasopressor-inotrope use. Comparisons will be made across these groups to better understand perioperative complications.
Participants will be followed for up to one year to assess thromboembolic complications and mortality at 30 and 90 days, and one year after surgery or treatment. The study will collect data related to coagulation abnormalities during the first 24 hours after surgery and track pathogens and disease severity for up to 30 days. This detailed monitoring aims to optimize perioperative care for patients with infective endocarditis and valve disease.
CONDITIONS
Brief Title
The ENDOCARDITIS AUMC Data Collection
Research Team
J
Jennifer S Breel, MPA,MSc
H
Henning Hermanns, MD,PhD
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Patients over 18 years old
Dutch or English speaking
All patients with infective endocarditis admitted to Amsterdam UMC during the study period
Patients with infective endocarditis scheduled for cardiac valve surgery compared to matched patients scheduled for similar surgery due to non-infectious reasons
You will not qualify if you...
Previous history of coagulation disorders
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 30 days
Participants undergo assessments related to their infective endocarditis status and valve disease before any treatment or observation.
1 to 2 visits depending on clinical status
Monitoring
Duration - Up to 1 year
Participants who undergo routine care are observed for perioperative coagulation abnormalities, transfusion requirements, bleeding scores, and complications including thromboembolic events and mortality.
Follow-up visits at 30 days, 90 days, and 1 year
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Clinical presentation, etiology, and outcome of infective endocarditis in the 21st century: the International Collaboration on Endocarditis-Prospective Cohort Study.