BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

Официальное название

BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)

Обзор

The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support. The main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care. Participants will be randomised to either anticoagulation with Bivalirudin or anticoagulation with Unfractionated Heparin.

Подробное описание

Rationale:

Anticoagulation whilst on extracorporeal membrane oxygenation (ECMO) is required. Bleeding and thrombotic complications whilst on ECMO are common and may effect the patient outcome. The optimal anticoagulant for ECMO patients is not clear and there exists no randomised control trial data comparing anticoagulants on ECMO. This Phase 2b trial will provide data to enable larger definitive phase III trials to determine the best anticoagulant whilst on ECMO.

Hypothesis: Hypothesis: In adults ECMO patients'; anticoagulation with Bivalirudin results in more samples within therapeutic range than unfractionated Heparin. Total anticoagulation costs with Bivalirudin are similar to unfractionated Heparin.

The objectives of this study is to assess anticoagulation protocol of bivalirudin versus unfractionated heparin and assess the to the cost of each protocol.

Вмешательства

• Препарат Unfractionated heparin
  Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
• Препарат Bivalirudin
  Bivalirudin protocol with target aPTT 50-70 seconds

Первичные конечные точки

• Time in therapeutic range [Срок оценки: 30 days]

Вторичные конечные точки (12)

• Enrolment rate [Срок оценки: 30 days]
• Reasons for non-enrolment [Срок оценки: 30 days]
• Crossover between arms [Срок оценки: 30 days]
• Circuit changes [Срок оценки: 30 days]
• Daily mean aPTT and anti-Xa [Срок оценки: 30 days]
• Serious adverse events (SAEs) [Срок оценки: 30 days]
• Protocol violations [Срок оценки: 30 days]
• Thrombotic events [Срок оценки: 30 days]
• Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH) [Срок оценки: 30 days]
• Bleeding events defined by Bleeding Academic Research Consortium (BARC) [Срок оценки: 30 days]
• Survival to Intensive care Unit (ICU) discharge [Срок оценки: 30 days]
• Survival to hospital discharge [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Patients receiving ECMO
• Age: 18 years or older
• Ability to randomise the patient within 4 hours of ECMO support initiation

Критерии исключения

• Post-cardiotomy ECMO patients
• Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding
• Heparin induced thrombotic thrombocytopenia syndrome
• Where the patient is expected to be disconnected from ECMO in the next day after cannulation.
• Limitations of care put in place either through patient wishes or the treating medical teams
• Other reason where the treating physician deems the study is not in the patient's best interest
• Patients who are suspected or confirmed to be pregnant
• Inherited bleeding or thrombotic disorders, Systemic Lupus Erythematosus patients

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Royal Prince Alfred Hospital — Sydney

Идентификаторы

NCT: NCT05959252 · 2023/ETH00443

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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