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Идёт набор NCT06357403

Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients

— Наблюдательное Thrombosis Pulmonary Embolism Enoxaparin

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Anti-factor Xa activity calibrated for enoxaparin.
Кому может быть актуально
Состояния в реестре: Thrombosis, Pulmonary Embolism, Enoxaparin. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients: a Prospective Multicentre Cohort Study

Обзор

The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are: * What is the association between antiXa and VTE? * What is the association between antiXa and symptomatic, respectively incidental, VTE? * How is pharmacological anticoagulation with enoxaparin related to measured antiXa? * What is the association between antiXa and bleeding complications. * What is the incidence of venous thromboembolism in patients treated at an intensive care unit? * How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital.

Вмешательства

  • Диагностический тест Anti-factor Xa activity calibrated for enoxaparin
    Anti-factor Xa activity calibrated for enoxaparin

Первичные конечные точки

  • Number of patients with new-onset venous thromboembolism [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
Вторичные конечные точки (12)
  • Number of patients with new-onset upper extremity deep vein thrombosis [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset lower extremity deep vein thrombosis [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset central vein thrombosis [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset symptomatic upper extremity deep vein thrombosis [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset symptomatic lower extremity deep vein thrombosis [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset incidental upper extremity deep vein thrombosis [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset incidental lower extremity deep vein thrombosis [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset pulmonary embolism [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset symptomatic pulmonary embolism [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with new-onset incidental pulmonary embolism [Срок оценки: until discharge from the intensive care unit or up to 14 days after study inclusion]
  • Number of patients with venous thromboembolism [Срок оценки: prevalent at study enrolment]
  • Number of patients with deep vein thrombosis [Срок оценки: prevalent at study enrolment]

Критерии участия

Критерии включения

  • Age over 18 years at the time of intensive care unit admission
  • Admission to a participating intensive care unit within the last 24 hours
  • Expected discharge is later than 48 hours after enrolment

Критерии исключения

  • Therapeutic anticoagulation, defined as enoxaparin dose of at least 100 IE/kg when given twice daily or of at least 150 IE/kg when given once daily
  • Extracorporeal membrane oxygenation in place or planned within 48 hours of study enrolment
  • Planned regular administration of vitamin K antagonists, unfractionated heparin, low molecular weight heparin other than enoxaparin, thrombin inhibitors or factor X inhibitors within the observation period
  • Estimated life expectancy below 48 hours or comfort terminal care order in place
  • Previously diagnosed heparin-induced thrombocytopenia
  • Pre-operative admission for elective surgery
  • Previous enrolment in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Австрия · 3 центра
  • Department of Internal Medicine, Medical University of Graz — Graz
  • Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medica — Innsbruck
  • Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University o — Vienna

Идентификаторы

NCT: NCT06357403 · AntiXa-ICU 1881/2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗