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Набор скоро начнётся NCT07597278

Quantra QPlus in Pediatric Cardiovascular Procedures

— Наблюдательное Blood Loss, Surgical

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: Quantra System.
Кому может быть актуально
Состояния в реестре: Blood Loss, Surgical. Базовые параметры: до 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
США
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

Evaluation of the Clinical Performance of the Quantra System With the QPlus Cartridge in Pediatric Patients Undergoing Cardiovascular Procedures

Обзор

This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.

Подробное описание

Pediatric patients that require major sugical procedures, such as cardiac surgery, are especially vulnerable to perioperative coagulopathy due to age-related immaturity of the hemostatic system, exposure to hemodilution from circuit primes or intravenous volume loading, hypothermia during complex interventions, and the intrinsic bleeding of invasive cardiac procedures. These factors can produce clinically significant perioperative bleeding driven by platelet dysfunction, hypofibrinogenemia and other hemostatic defects. The Quantra System with the QPlus Cartridge is desinged to assess coagulation function of a whole blood sample at the point-of-care by measuring changes in the viscoelastic properties during clot formation. This multi-center study is aimed to demonstrate the performance of the QPlus Cartridge for its ability to aid in the evaluation of a pediatric patient's hemostatic status before, during and after cardiovascular procedures.

Вмешательства

  • Диагностический тест Quantra System
    Diagnostic device to monitor the coagulation properties of a whole blood sample at the point-of-care.

Первичные конечные точки

  • Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT [Срок оценки: 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.]
  • Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT [Срок оценки: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.]
  • Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10 [Срок оценки: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.]
  • Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10 [Срок оценки: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.]
  • Correlation of QPlus CT to TEG 6S CK-R [Срок оценки: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.]
  • Correlation of QPlus CTH to TEG 6S CKH-R [Срок оценки: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.]
  • Correlation of QPlus CS to TEG 6S CKH-MA [Срок оценки: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.]
  • Correlation of QPlus FCS to TEG 6S FFH-MA [Срок оценки: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.]

Критерии участия

Критерии включения

  • Subject is <18 years of age.
  • Subject is undergoing a cardiovascular procedure OR subject underwent cardiovascular surgery and presents with acute bleeding or suspected hypocoagulation/hypercoagulation in a post-surgical unit.
  • Subject's parent(s) or guardian(s) has signed an informed consent form. If required, subject has signed an assent form.

Критерии исключения

  • Corrected gestational age <37 weeks.
  • Subject is enrolled in a study that might confound the result of the proposed study.
  • Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 3 центра
  • UCLA Mattel Children's Hospital — Los Angeles
  • Children's Healthcare of Atlanta — Atlanta
  • Children's Hospital of Philadelphia — Philadelphia

Идентификаторы

NCT: NCT07597278 · HEMCS-051

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗