Function of Platelets Used for Transfusions

NCT ID: NCT05038722

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-22
• Study Completion Date: 2026-12-31

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.

Conditions

Thrombocytopenia; Hematologic Malignancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Platelet transfusion

Transfusion of platelet concentrates according to routine practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Participant requiring HLA-matched platelet transfusions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sofia Ramström

OTHER

Sponsor Role: lead

Responsible Party

Sofia Ramström

Associated Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sofia Ramström, Ass. Prof

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Region Östergötland

Linköping, , Sweden

Örebro University

Örebro, , Sweden

Countries

Sweden

Other Identifiers

2020-05968

Identifier Type: -

Identifier Source: org_study_id