Идёт набор NCT06493227

Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery

Без фазы С лечением Thoracic Surgery Heart Diseases Fibrinolysis Shutdown

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: No routine fibrinolysis inhibitors after surgery, Routine fibrinolysis inhibitors after surgery.
Кому может быть актуально: Состояния в реестре: Thoracic Surgery, Heart Diseases, Fibrinolysis Shutdown. 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: Россия
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

The Practice of Routine Extended Perioperative Administration of Fibrinolysis Inhibitors to Reduce the Risk of Bleeding in Cardiac Surgery. Multicenter Prospective Randomized Cluster Crossover Study

Обзор

PRIORITY is a pragmatic, multi-center, cluster crossover trial that aims to evaluate whether implementing a policy of routine extended (intraoperative and 4 hour after transfer to ICU) use of fibrinolysis inhibitors leads to a decrease in post-operative blood transfusion compared to a policy that only involves intraoperative use.

Подробное описание

Routine use of fibrinolysis inhibitors is strongly recommended in cardiac surgery (recommendation level 1A). However, despite numerous studies on the pharmacodynamics and clinical effects of these drugs, there is still no consensus on the optimal dose and dosage regimen. As a result, there is wide variability in the use of fibrinolysis inhibitors across different clinics. Several studies have shown that peak activation of fibrinolysis occurs during cardiopulmonary bypass. However, elevated levels of markers of fibrinolytic activity in the blood plasma are observed for at least 2 hours after surgery and 4 hours after heparin neutralization. This suggests the potential for extended use of fibrinolysis inhibitors after surgery. There have been limited attempts to investigate the effectiveness of postoperative administration of fibrinolysis inhibitors, and these studies have been conducted on small samples or with retrospective designs. The authors of these studies were unable to identify the benefits of postoperative administration in terms of reducing bleeding risk and the need for blood transfusions. However, postoperative infusion of fibrinolysis inhibitors demonstrated a comparable safety profile. There is evidence suggesting that repeated administration of fibrinolysis inhibitors after cardiopulmonary bypass, rather than a single dose at the beginning of surgery, may be more beneficial. Due to uncertainty regarding the best approach (routine extended use of fibrinolysis inhibitors or no routine extended use of fibrinolysis inhibitors), we will compare the effects of a hospital policy that includes routine administration of fibrinolysis inhibitors 4 hours after surgery to a policy that avoids routine postoperative administration. The comparison will focus on the blood transfusion requirement during hospitalization among patients undergoing open heart surgery.

Вмешательства

Другое No routine fibrinolysis inhibitors after surgery
Tranexamic acid or epsilon-aminocaproic acid should be administered intravenously during surgery. The dosage and method of administration should be followed according to the routine practice of the participating site.
Другое Routine fibrinolysis inhibitors after surgery
During surgery, it is recommended to administer 70% of the routine dose of Tranexamic acid or epsilon-aminocaproic acid intravenously. Following the surgery, the remaining 30% of this dose should be administered as a continuous intravenous infusion over the course of the first 4 hours.

Первичные конечные точки

RBC transfusion [Срок оценки: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months]

Вторичные конечные точки (4)

Hospital stay [Срок оценки: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months]
Redo surgery requirement [Срок оценки: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months]
Haemoglobin on discharge [Срок оценки: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months]
Total blood products requirement [Срок оценки: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months]

Критерии участия

Критерии включения

A hospital that performs a minimum of 250 open heart interventions per year.
Consent from hospital physicians regarding the prophylactic use of fibrinolysis inhibitors (more than 95% of physicians involved in the treatment of adult patients (>18 years) agree to adhere to the strategy of using fibrinolysis inhibitors as prescribed by the study protocol).