Platelet Function After Cardiac Surgery.

Официальное название

Platelet Count and Function After Usage of Two Different Cell Saver Devices During Cardiac Surgery: a Randomized Controlled Multi-center Equivalence Trial.

Обзор

Intraoperative cell salvage is commonly used in cardiac surgery to reduce the administration of allogeneic red blood cells and thus improve the outcome for the patient. When processing the salvaged blood, however, a large part of the patient's plasma is washed out. This is a disadvantage with regard to an optimal coagulation situation after cardiac surgery. There are currently various cell saver systems on the market. According to the manufacturers, the plasma is returned to the patient in different quantities as part of the processing procedure. Thus, it can be assumed that in addition to red blood cells, platelets (part of plasma) are retransfused and contribute to an optimized coagulation. Unfortunately, there is a lack of studies in this regard in the cardiac surgery population. The investigators aim to study the performance of two different cell saver devices regarding preservation of platelet number and function.

Вмешательства

• Устройство Autologous blood cell salvage with in-house device
  In addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood.
• Устройство Autologous cell salvage with i-Sep SAME device
  In addition to standard procedures in this patient population, study participants will receive point-of-care analysis of platelet function and coagulation (laboratory analysis and viscoelastic tests, if not already provided by the responsible anesthesiologist) based on the clinical situation, at different time points before and after retransfusion of processed cell salvage blood.

Первичные конечные точки

• Platelet number [Срок оценки: Perioperative period (begins on the day of surgery and ends on the day after surgery)]

Вторичные конечные точки (6)

• Platelet function measured by multiple electrode aggregometry [Срок оценки: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
• Platelet function measured by platelet activation markers (P-selectin) [Срок оценки: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
• Platelet function measured by platelet activation markers (GPIb and GPIIb) [Срок оценки: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
• Platelet function measured with viscoelastic point-of-care test (Clotpro) [Срок оценки: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
• Platelet function measured with viscoelastic point-of-care test (ROTEM) [Срок оценки: Perioperative period (begins on the day of surgery and ends on the day after surgery)]
• Number of allogeneic blood products transfused [Срок оценки: Perioperative period (begins on the day of surgery and ends on the day after surgery)]

Критерии участия

Критерии включения

• Age >18 years
• Elective high risk cardiac surgery with cardiopulmonary bypass usage
• Cardiopulmonary bypass time > 120 minutes
• Written informed consent

Критерии исключения

• Preoperative use of oral or intravenous anti-coagulants or antiplatelet agents (except aspirin)
• Inability to understand and sign the informed consent form (e.g. language problems, dementia, mental disorders).

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

Простое слепое

Основная цель

Диагностика

Центры проведения

Швейцария · 1 центр

• Department of Anesthesiology and Pain Medicine — Bern

Идентификаторы

NCT: NCT06405516 · BASEC 2023-D0074

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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