Clinical Study of Combined Platelet Transfusion

Официальное название

Combined Platelet Transfusion:A Single-arm, Open, Prospective, Non-inferiority Clinical Trial

Обзор

Platelet transfusion is an irreplaceable and important treatment method for clinical prevention and treatment of thrombocytopenia or platelet dysfunction. Due to various factors, it is difficult to achieve platelet ABO complete homotypic transfusion in clinical practice. When ABO-compatible platelets cannot be obtained, plasma-reduced platelets, platelets with low anti-A or anti-B titers are often used in clinical practice to reduce the risk of ABO-incompatible platelet-compatible transfusion reactions. The combined platelets prepared in this study can achieve ABO primary and secondary side compatible infusion.

Подробное описание

Combined platelet transfusion is a single-arm, open, prospective, non-inferiority study initiated by researchers. Patients with hematological diseases who were admitted to the research unit and applied for platelet transfusion within two years were included in the study after informed consent. When the subjects applied for platelet transfusion during the study period, ABO homotype platelet transfusion was preferred. When there was no ABO homotype platelet in the inventory, ABO primary and secondary side compatible combined platelet transfusion was given. The study period was 2 years, including 15 months of enrollment, 6 months of treatment, and 3 months of follow-up after the end of the treatment period

Вмешательства

• Комбинированный продукт Combined platelets
  1 therapeutic dose combined platelet contained no less than 2.5 ×10\^11 platelets as a quality standard.

Первичные конечные точки

• Efficacy evaluation of combined platelet transfusion [Срок оценки: From the start of infusion of combined platelets to 6 months later]

Вторичные конечные точки (7)

• Adverse reactions of blood transfusion [Срок оценки: From the start of infusion of combined platelets to 6 months later]
• Safety evaluation of combined platelet transfusion [Срок оценки: From the start of infusion of combined platelets to 6 months later]
• Platelet antibody screening [Срок оценки: From the start of infusion of combined platelets to 6 months later]
• Adverse events of blood transfusion [Срок оценки: From the start of infusion of combined platelets to 6 months later]
• Waiting time for platelet transfusion [Срок оценки: From the start of infusion of combined platelets to 6 months later]
• Interval time, frequency and total amount of platelet transfusion [Срок оценки: From the start of infusion of combined platelets to 6 months later]
• Bleeding adverse events during hospitalization [Срок оценки: From the start of infusion of combined platelets to 6 months later]

Критерии участия

Критерии включения

• 1\. Aged 18-65 years; 2. Disease treatment in the research hospital; 3. Applied for platelet transfusion therapy.

Критерии исключения

• 1\. One month before the start of this study, he participated in other clinical trials of drugs and instruments related to platelet transfusion efficacy; 2. Without platelet transfusion indications; 3. Only received platelet transfusion in the outpatient department and left the hospital without efficacy evaluation after transfusion; 4. Gave up platelet transfusion therapy for any reason after enrollment; 5. Transferred or discharged from hospital for any reason before platelet transfusion after enrollment; 6. Did not receive combined platelet transfusion during the 6-month treatment period after enrollment

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Li Zhang — Чэнду

Идентификаторы

NCT: NCT06613425 · 2024EC4-ky004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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