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Набор скоро начнётся NCT07530393

Blood Viscosity and Outcomes After Elective Craniotomy

Наблюдательное Postoperative Complications Intracranial Surgery

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: Observational Assessment of Blood Viscosity.
Кому может быть актуально
Состояния в реестре: Postoperative Complications, Intracranial Surgery. Базовые параметры: 18 лет — 80 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 →
Официальное название

Association of Intraoperative Blood Viscosity With Cerebral Oxygenation and Postoperative Composite Complications in Adults Undergoing Elective Intracranial Craniotomy: A Prospective Observational Study

Обзор

This prospective observational study aims to evaluate the association between intraoperative blood viscosity and postoperative clinical outcomes in adult patients undergoing elective intracranial craniotomy. Blood viscosity is an important determinant of microcirculatory flow and cerebral perfusion, but its role in perioperative outcomes remains unclear. In this study, intraoperative blood viscosity and related hematologic parameters will be measured, and their relationships with cerebral oxygenation and postoperative complications will be analyzed. The study will enroll adult patients undergoing elective intracranial surgery at a single tertiary center. The findings of this study may improve understanding of perioperative hemodynamic and hemorheological factors and help identify potential risk markers for adverse postoperative outcomes.

Вмешательства

  • Другое Observational Assessment of Blood Viscosity
    No intervention is assigned. Intraoperative blood viscosity and clinical variables are measured as part of routine care and analyzed for association with postoperative outcomes.

Первичные конечные точки

  • Number of participants with one or more postoperative composite complications within 30 days after surgery [Срок оценки: Up to postoperative day 30]
Вторичные конечные точки (12)
  • Change in high-shear blood viscosity from after induction of anesthesia to near the end of surgery [Срок оценки: After induction of anesthesia and near the end of surgery]
  • Change in low-shear blood viscosity from after induction of anesthesia to near the end of surgery [Срок оценки: After induction of anesthesia and near the end of surgery]
  • Change in TODI from after induction of anesthesia to near the end of surgery [Срок оценки: After induction of anesthesia and near the end of surgery]
  • Intraoperative regional cerebral oxygen saturation desaturation burden [Срок оценки: From after induction of anesthesia to end of surgery]
  • Area under the predefined regional cerebral oxygen saturation desaturation threshold curve during surgery [Срок оценки: From after induction of anesthesia to end of surgery]
  • Number of participants with postoperative neurologic complications within 30 days after surgery [Срок оценки: Up to postoperative day 30]
  • Number of participants with postoperative respiratory complications within 30 days after surgery [Срок оценки: Up to postoperative day 30]
  • Number of participants with postoperative cardiovascular complications within 30 days after surgery [Срок оценки: Up to postoperative day 30]
  • Number of participants with acute kidney injury within 30 days after surgery [Срок оценки: Up to postoperative day 30]
  • Number of participants with postoperative infectious complications within 30 days after surgery [Срок оценки: Up to postoperative day 30]
  • Number of participants requiring reoperation or major postoperative intervention within 30 days after surgery [Срок оценки: Up to postoperative day 30]
  • Number of participants with all-cause mortality within 30 days after surgery [Срок оценки: Up to postoperative day 30]

Критерии участия

Критерии включения

  • Adults aged 18 to 80 years
  • Patients scheduled to undergo elective intracranial craniotomy
  • Patients requiring intraoperative arterial catheterization and routine arterial blood gas analysis
  • Patients who provide written informed consent

Критерии исключения

  • Emergency surgery
  • Patients in whom participation or follow-up is considered difficult by the investigator
  • Patients unable to provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Asan Medical Center — Seoul

Идентификаторы

NCT: NCT07530393 · AMC (2026-0404)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗