跳至主要内容
临床试验/NCT05139589
NCT05139589招募中不适用

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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
Thromboembolic complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Previous history of coagulation disorders

结局指标

主要结局

Thromboembolic complications

时间窗: up to 1 year

Any thromboembolic complications occuring between surgery and 1 year post operatively (incidence, class and severity)

次要结局

  • Incidence of perioperative coagulation abnormalities(First 24 hours after surgery)
  • Differences in incidence of pathogens and the relation with disease severity(Up to 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Breel

Research Coordinator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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