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Набор по приглашению NCT05038722

Function of Platelets Used for Transfusions

Наблюдательное Thrombocytopenia Hematologic Malignancy

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: Platelet transfusion.
Кому может быть актуально
Состояния в реестре: Thrombocytopenia, Hematologic Malignancy. Базовые параметры: от 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
Швеция
Следующий шаг
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Официальное название

Flödescytometrisk utvärdering av Den Blodstillande förmågan Hos Trombocyter Avsedda för Transfusion

Обзор

Cytotoxic treatment for malignant hematologic disorders often casue thrombocytopenia that can result in life threatening bleedings. This is prevented by platelet transfusions but these can cause serious transfusion reactions and thus the number of transused platelet concentrates should be limited. It is therefore important that the platelet concentrates contain functional platelets with long circulation time in the bloodstream. We have developed a method with flow cytometry to measure platelet function markers. It allows us to determine which pathways that are initiated upon activation. The aim of this project is to assess to what degree spontaneous activation of platelets as well as their activation capacity affects the transfusion response (i.e. uptake in the circulation and circulation time) in the recipient. The hypothesis is that transfusion of platelets with low spontaneous activation and high activation capacity will lead to a higher transfusion response in the recipient.

Подробное описание

Cytotoxic treatment for malignant hematologic disorders often casue thrombocytopenia that can result in life threatening bleedings. This is prevented by platelet transfusions but these can cause serious transfusion reactions and thus the number of transused platelet concentrates should be limited. It is therefore important that the platelet concentrates contain functional platelets with long circulation time in the bloodstream.

The role of platelets in hemostasis is complex. Upon vascular injury, platelets adhere at the injured site where they become activated, release their granule content and aggregate. Activation include changes in receptors, expression of activation markers and become procaoagulant. We have developed a method with flow cytometry to measures these platelet function markers. It allows us to determine which pathways that are initiated upon activation.

Platelets can be stored a maximum of 5-7 days before transfusion. However, the preparation process and subsequent storage can result in platelet lesions, affecting their ability to promote hemostasis and circulate after transfusion.

The aim of this project is to assess to what degree spontaneous activation of platelets as well as their activation capacity affects the transfusion response (i.e. uptake in the circulation and circulation time) in the recipient.

The hypothesis is that transfusion of platelets with low spontaneous activation and high activation capacity will lead to a higher transfusion response in the recipient.

We will be able to examine how this relates to platelet processing methods and storage duration.

Platelets will be transfused on normal indications to participants at the hematology ward. The platelet concentrates choosen to be transfused will be done according to regular routines at the blood center. We will thus not control what concentrates are transfused (i.e. preparation method and storage time) and hence included in the study.

A small sample will be taken from the platelet concentrate shortly before transfusion and platelet function analysed with the flow cytometry method. Transfusion response will be assessed in the participant by calculation of corrected count increment (CCI) which relates the increase in platelet concentration after transfusion to the number of platelets transfused and the blood volume. CCI is calculated at 1 and 24-hours after transfusion. Clincial variables that might affect the transfusion response such as infection and fever will be registered as well as bleeding. The number of days to next platelet transfusion will be followed up.

Вмешательства

  • Другое Platelet transfusion
    Transfusion of platelet concentrates according to routine practice.

Первичные конечные точки

  • Corrected count increment (CCI) [Срок оценки: 1- and 24 hours after transfusion.]
  • Spontaneous and agonist induced expression of platelet activation markers on platelets in platelet concentrates. [Срок оценки: Measured on the day of transfusion prior to transfusion.]
  • Spontaneous and agonist induced formation of platelet subpopulations in platelet concentrates. [Срок оценки: Measured on the day of transfusion prior to transfusion.]
Вторичные конечные точки (5)
  • Treatment of infection. [Срок оценки: Prior to transfusion.]
  • Signs of infection - fever. [Срок оценки: Prior to transfusion.]
  • Bleeding. [Срок оценки: Prior to platelet transfusion and 24-hours after the transfusion.]
  • Number of platelet transfusions [Срок оценки: From beginning of the cytotoxic treatment cycle to inclusion in the study, i.e receiving a study concentrate.]
  • Days to next platelet transfusion. [Срок оценки: After the study platelet concentrate was transfused, followed for up to two weeks after transfusion.]

Критерии участия

Критерии включения

  • Participant undergoing treatment for malignant hematologic disorders
  • Thrombocytopenia
  • Require platelet transfusion

Критерии исключения

\- Participant requiring HLA-matched platelet transfusions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 2 центра
  • Region Östergötland — Linköping
  • Örebro University — Örebro

Идентификаторы

NCT: NCT05038722 · 2020-05968

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗