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Function of Platelets Used for Transfusions

Flödescytometrisk utvärdering av Den Blodstillande förmågan Hos Trombocyter Avsedda för Transfusion

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05038722
Enrollment
240
Registered
2021-09-09
Start date
2018-11-22
Completion date
2026-12-31
Last updated
2023-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancy, Thrombocytopenia

Brief summary

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.

Detailed description

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.

Interventions

OTHERPlatelet transfusion

Transfusion of platelet concentrates according to routine practice.

Sponsors

Sofia Ramström
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- Participant requiring HLA-matched platelet transfusions.

Design outcomes

Primary

MeasureTime frameDescription
Corrected count increment (CCI)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 expression of platelet activation markers on platelets in platelet concentrates.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.
Spontaneous and agonist induced formation of platelet subpopulations in platelet concentrates.Measured on the day of transfusion prior to transfusion.Percentage of normal sized platelets, small platelets and platelet fragments (microparticles).

Secondary

MeasureTime frameDescription
Number of platelet transfusionsFrom beginning of the cytotoxic treatment cycle to inclusion in the study, i.e receiving a study concentrate.Total number of platelet transfusions a participant recieved before being incuded in the study (i.e before being transfused with the study specific platelet concentrate) in the treatment cycle.
Treatment of infection.Prior to transfusion.Use of antibiotics.
Days to next platelet transfusion.After the study platelet concentrate was transfused, followed for up to two weeks after transfusion.The number of days until the next platelet transfusion occured after being transfused with the study specific platelet concentrate.
Signs of infection - fever.Prior to transfusion.Body temperature measurement.
Bleeding.Prior to platelet transfusion and 24-hours after the transfusion.Signs of bleeding according to WHO-scale (0-4, where 4 is the worst outcome).

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026