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Идёт набор NCT06727669

Longitudinal Cohort of Thrombosis and Hemostasis Diseases

Наблюдательное Immune Thrombocytopenia Thrombotic Thrombocytopenic Purpura Hemophilia A, Acquired Disseminated Intravascular Coagulation

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Immune Thrombocytopenia, Thrombotic Thrombocytopenic Purpura, Hemophilia A, Acquired, Disseminated Intravascular Coagulation. Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This is a multicenter, prospective, longitudinal, observational cohort study to investigate thrombosis and hemostasis diseases in Chinese patients. This study will collect basic information, diagnostic and treatment information, as well as medical expense information of patients from medical records.The incidence and risk factors of thrombosis and hemostasis diseases, the treatment methods, prognosis and medical expenses of these patients in China will be analyzed. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Подробное описание

Thrombosis and hemostasis diseases are a group of high-risk hematological diseases, characterized by bleeding or hypercoagulability caused by congenital or acquired abnormalities in hemostasis, coagulation, and fibrinolysis. Thrombosis and hemostasis diseases included various bleeding and thrombotic diseases such as primary immune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP), hemophilia, disseminated intravascular coagulation (DIC), thrombophilia, pregnancy with ITP, pregnancy with prethrombotic state (such as protein C, protein S deficiency, etc.), deep vein thrombosis, pulmonary embolism, thrombocytopenia and coagulation abnormalities after hematopoietic stem cell transplantation, and so on. Thrombosis and hemostasis diseases have a high incidence rate, may affect patients' quality of life and even are associated with the poor survival. However, current studies are mostly based on data from limited sample size cohorts, lacking comprehensive and large-scale prospective cohort studies.

This is a multicenter, prospective, longitudinal, observational cohort study investigating the incidence and risk factors of thrombosis and hemostasis diseases, and to analyze the treatment methods, prognosis and medical expenses of these patients in China.This study will collect basic information, diagnostic and treatment information, as well as medical expense information of patients from medical records. The study will use questionnaire to measure the exposure of patients, and prospectively follow-up to collect the prognosis information.

Первичные конечные точки

  • Prognosis [Срок оценки: 5 years]
Вторичные конечные точки (6)
  • Incidence [Срок оценки: 5 years]
  • Distribution [Срок оценки: 5 years]
  • Overall response rate [Срок оценки: 180 days]
  • Long-term overall remission rate [Срок оценки: 1 years]
  • Safety of treatment [Срок оценки: 1 years]
  • Health economic evaluation [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Patients who were diagnosed as thrombosis and hemostasis diseases.

Критерии исключения

  • Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.
  • Patients with alcohol and drug addictions or mental illness affect their ability to comply with study requirements.
  • According to the investigator, there are conditions that may endanger the patient's safety or affect his/her compliance.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 5 центров
  • Peking University Insititute of Hematology, Peking University People's Hospital — Пекин
  • Department of Hematology, Beijing Friendship Hospital, Capital Medical University — Пекин
  • Department of Hematology, Beijing Hospital — Пекин
  • The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
  • Xinqiao Hospital, Army Military Medical University — Чунцин

Идентификаторы

NCT: NCT06727669 · 2024PHB401-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗