Function of Platelets Used for Transfusions

NCT05038722 | Enrolling By Invitation

• 1 other identifier: 2020-05968
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Thrombocytopenia; Hematologic Malignancy

Outcome Measures

Primary Outcomes (3)

• Corrected count increment (CCI)

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

  1- and 24 hours after transfusion.

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

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

  Measured on the day of transfusion prior to transfusion.

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

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

  Measured on the day of transfusion prior to transfusion.

Secondary Outcomes (5)

• Treatment of infection.

  Prior to 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.

• Days to next platelet transfusion.

  After the study platelet concentrate was transfused, followed for up to two weeks after transfusion.

Interventions

Platelet transfusion OTHER

Transfusion of platelet concentrates according to routine practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with malignant hematologic disorders undergoing cancer treatment at the Hematology ward.

You may qualify if:

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

You may not qualify if:

• \- Participant requiring HLA-matched platelet transfusions.

Sponsors & Collaborators

• Sofia Ramström: lead

Study Sites (2)

Region Östergötland

Linköping, 58185, Sweden

Location

Örebro University

Örebro, 70182, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples without DNA retained from the platelet concentrates used for transfusion

MeSH Terms

Conditions

Thrombocytopenia; Hematologic Neoplasms

Interventions

Platelet Transfusion

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Sofia Ramström, Ass. Prof

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 9, 2021
• Study Start: November 22, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication, ending 18 months following article publication.
• Access Criteria: Researchers who provide a sound methodological proposal in order to achieve aims in the approved proposal. Proposals should be adressed to the principal investigator.

Locations

SE (2)