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Набор скоро начнётся NCT07352072

Incidence of Bleeding, Thrombosis and Transfusion Requirements in ICU Patients With COVID-19 Supported With Veno-venous Extracorporeal Membrane Oxygenation

Наблюдательное VV ECMO Bleeding Thrombosis Transfusion Adverse Reaction

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: VV ECMO, Bleeding, Thrombosis, Transfusion Adverse Reaction. Базовые параметры: Без ограничений · 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Incidence of Bleeding, Thrombosis and Transfusion Requirements in ICU Patients With COVID-19 Supported With Veno-venous Extracorporeal Membrane Oxygenation: a Single-center Retrospective Cohort Study

Обзор

The investigators aim to assess the risk of bleeding and thrombo-embolic complications as well as benefit and harm of blood product transfusion and anticoagulation therapy in adult ICU patients with COVID-19 supported with V-V ECMO

Подробное описание

During the SARS-CoV-2 (COVID-19) pandemic millions of people were affected worldwide, some only experiencing minor symptoms whilst some developed acute respiratory distress syndrome (ARDS) requiring admission to the intensive care unit (ICU). ARDS is a life-threatening condition with mortality ranging from 35-48 %. Gas exchange can be severely impaired and, in some cases, conventional mechanical ventilation and adjunct therapies cannot accomplish adequate oxygenation. Veno-venous extracorporeal membrane oxygenation (V-V ECMO) is recommended as a rescue-support for refractory hypoxemia in ARDS also following COVID-19 infection and has been utilised widely. However, optimal management is difficult with prolonged ECMO duration in ARDS patients with COVID-19 and reported survival rates vary considerably 34-66

%. Complications include severe bleeding requiring more red cell transfusions and thrombotic complications, which are common despite increased risk of bleeding. Both bleeding and thrombosis are associated with increased mortality and balancing the opposing risks is challenging in daily management. On one hand, patients are routinely exposed to anticoagulant therapy (e.g. systemic heparin for the ECMO circuit operation), but on the other hand, patients are commonly exposed to blood product transfusions. The timing, monitoring, efficacy and safety of both blood product transfusion and anticoagulant therapy remains poorly understood. The investigators therefore aim to assess the risk of bleeding and thrombo-embolic complications as well as benefit and harm of blood product transfusion and anticoagulation therapy in adult ICU patients with COVID-19 supported with V-V ECMO.

Objectives

1. To assess the incidence, site and risks of bleeding and thrombo-embolic events in ICU patients with COVID-19 supported with V-V ECMO. 2. To assess the quantity of transfused blood products. 3. To assess the clinical practice of anticoagulant therapy in this cohort. 4. To assess the incidence of transfusions-related serious adverse events.

Первичные конечные точки

  • Bleeding events [Срок оценки: 90 days]
Вторичные конечные точки (4)
  • Thrombo-embolic events [Срок оценки: 90 days]
  • Use of blood products transfusion in the ICU [Срок оценки: 90 days]
  • Use of anticoagulant therapy [Срок оценки: 90 days]
  • Transfusion-related serious adverse events [Срок оценки: 90 days]

Критерии участия

Критерии включения

  • Adults
  • Polymerase chain reaction (PCR) verified COVID-19 infection
  • Supported with V-V ECMO in this center

Критерии исключения

\- none

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 1 центр
  • Department of cardiothoracic anaesthsia and intensive care 4141 — Copenhagen

Идентификаторы

NCT: NCT07352072 · P-2025-19510 · R-25054929

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗