Platelet Products Tested With the ThromboLUX® Platelet Quality Test

Overview

The planned minimal risk study is a blinded study on consecutive transfusable platelet products. The aim of the study is to evaluate the quality of platelet components sampled prior to transfusion.

The primary patient transfusion outcome in this study is the 1-hour corrected count increment (1 hr CCI), which is a widely accepted clinical outcome measure. Platelet products will be sampled for ThromboLUX testing before being sent from the blood bank to the treatment center. After receipt at the treatment center, the platelet products will be used as per regular clinical practice, and the outcome data from each patient will be collected. At the end of the study, TLX Scores will be compared to the transfusion outcomes to determine if a low TLX Score is associated with a poor transfusion outcome.

During the course of the study, the TLX Score will not be known to the clinicians, or utilized in any way to decide if the platelet product should be transfused.

Full Title of Study: “Blinded Study on Consecutive Transfusable Platelet Products Tested With the ThromboLUX® Platelet Quality Test”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2014

Arms, Groups and Cohorts

  • Hematology-oncology
    • hematology-oncology outpatients requiring platelet transfusion

Clinical Trial Outcome Measures

Primary Measures

  • TLX Score Correlation with CCI
    • Time Frame: Patients are expected to be enrolled for an average of 6 months.
    • The value of the ThromboLUX Score (obtained from platelet products with the ThromboLUX platelet quality test system) to predict patient transfusion outcome (measured as 1hr corrected count increment CCI). The correlation between ThromboLUX score and 1hr CCI (study endpoint) will be reported at the end of the study

Participating in This Clinical Trial

Inclusion Criteria

  • adult hematology-oncology outpatients
  • stable and thrombocytopenic

Exclusion Criteria

  • age <18 yrs
  • splenomegaly
  • unable to provide informed consent
  • pregnancy
  • acute promyelocytic leukemia
  • ITP (Idiopathic thrombocytopenic purpura)
  • HUS

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LightIntegra Technology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William A Heaton, MD, Principal Investigator, Northwell Health

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