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临床试验/NCT05038722
NCT05038722Enrolling By Invitation不适用

Flödescytometrisk utvärdering av Den Blodstillande förmågan Hos Trombocyter Avsedda för Transfusion

Sofia Ramström2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
240
试验地点
2
主要终点
Corrected count increment (CCI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Participant requiring HLA-matched platelet transfusions.

结局指标

主要结局

Corrected count increment (CCI)

时间窗: 1- and 24 hours after transfusion.

CCI relates the increase in platelet concentration in participants after transfusion to the number of platelets transfused and the participants blood volume.

Spontaneous and agonist induced formation of platelet subpopulations in platelet concentrates.

时间窗: Measured on the day of transfusion prior to transfusion.

Percentage of normal sized platelets, small platelets and platelet fragments (microparticles).

Spontaneous and agonist induced expression of platelet activation markers on platelets in platelet concentrates.

时间窗: Measured on the day of transfusion prior to transfusion.

Percentage of platelets expressing P-selectin, LAMP-1, phosphatidylserine and the active conformation of fibrinogen receptor.

次要结局

  • Treatment of infection.(Prior to transfusion.)
  • Days to next platelet transfusion.(After the study platelet concentrate was transfused, followed for up to two weeks after transfusion.)
  • Signs of infection - fever.(Prior to transfusion.)
  • Bleeding.(Prior to platelet transfusion and 24-hours after the transfusion.)
  • Number of platelet transfusions(From beginning of the cytotoxic treatment cycle to inclusion in the study, i.e receiving a study concentrate.)

研究者

发起方
Sofia Ramström
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sofia Ramström

Associated Professor

Örebro University, Sweden

研究点 (2)

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