Comparison of the Diagnosis Time of VET and SCL in Patients With Intraoperative Coagulopathy
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: SCL tests, POC viscoelastic tests.
- Кому может быть актуально
- Состояния в реестре: Arthritis of Knee, Arthritis of Hip, Spine, Prostate Cancer. Базовые параметры: от 19 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
- South Korea
- 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
Comparison of Time Taken for Diagnosing Intraoperative Coagulopathies: Point-of-care Viscoelastic Tests vs Standard Central Laboratory Tests
Обзор
The present study is a prospective, multi-center observational trial comparing the times taken to diagnose coagulopathies using point-of-care (POC) viscoelastic tests or standard central laboratory tests (SCL tests) in patients with intraoperative bleeding.
Подробное описание
The present study is a prospective multi-center observational trial comparing the time for diagnosing coagulopathies using POC viscoelastic tests, such as rotational thromboelastometry (ROTEM) and thromboelastography (TEG) and standard central laboratory tests (SCL test, such as PT-INR, aPTT, s-fibrinogen level, platelet count) in intraoperative bleeding patients.
The study will be performed during surgeries that are expected to entail a moderate to severe amount of bleeding and warrant the use of either POC viscoelastic tests, SCL tests, or both to determine the possible association of coagulopathy.
The tests will be conducted when an intraoperative condition requires identifying possible associations of coagulopathies during and after surgical bleeding. The test results will prompt appropriate coagulation management.
The primary objective is to compare the diagnosis time for intraoperative coagulopathy using the POC viscoelastic test or SCL test. The time will be defined as the time elapsed from the time obtaining a blood sample for the POC viscoelastic test or SCL test to the time acknowledging the test results.
Researchers hypothesized that using POC viscoelastic tests would shorten the time for diagnosis compared to SCL tests.
Вмешательства
- Диагностический тест SCL tests
applying PT-INR, serum-fibrinogen (Claus Method), serum-platelet count - Диагностический тест POC viscoelastic tests
applying ROTEM or TEG
Первичные конечные точки
- Time for establishing a diagnosis using viscoelastic test and SCL test, minute [Срок оценки: From the start and to the end of surgery, an average of 6 hours]
Вторичные конечные точки (6)
- Test results from viscoelastic test and SCL test [Срок оценки: From the start and to the end of surgery, an average of 6 hours]
- The difference in the percentages of patients that lead to the diagnosis of coagulopathies for viscoelastic test and SCL tests [Срок оценки: From the start and to the end of surgery, an average of 6 hours]
- Time for initiating a treatment, munute [Срок оценки: From the start and to the end of surgery, an average of 6 hours]
- Time taken to complete the delivery of the blood products to the operation room, minute [Срок оценки: From the start and to the end of surgery, an average of 6 hours]
- Amount of blood products transfused if indicated specific to each test, unit [Срок оценки: From the start and to the end of surgery, an average of 6 hours]
- comparisons of diagnosis time between POC-viscoelastic test and SCL test [Срок оценки: From the start and to the end of surgery, an average of 6 hours]
Критерии участия
Критерии включения
- patients who will undergo elective surgery with a high risk of moderate to severe amount of intraoperative bleeding or coagulopathy (e.g., cardiac surgery, joint replacement, spine surgery, hepatectomy, radical prostatectomy)
- patients who provide written informed consent
- patients who may warrant the intraoperative use of POC viscoelastic test or SCL test
Критерии исключения
- pregnancy
- withdrawal of consent
- termination of surgery without performing either POC viscoelastic test or SCL tests
- when the study conductor deems it inappropriate to proceed with the protocol with the patient
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
South Korea · 4 центра
- Asan Medical Center — Seoul
- Konkuk Univeristy Medical Center — Seoul
- Samsung Medical Center — Seoul
- Sooncheonhyang University — Seoul
Идентификаторы
NCT: NCT06637943 · HI22C1952-1-2-2