Platelet Products Tested With the ThromboLUX® Platelet Quality Test

Blinded Study on Consecutive Transfusable Platelet Products Tested With the ThromboLUX® Platelet Quality Test

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.

Study Overview

• Status: Completed
• Conditions: Poor Platelet Transfusion Outcome

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• United States
  • New York
    • New Hyde Park, New York, United States, 11042
      • Monter Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consists of adults who require treatment of a blood cancer with platelet transfusion(s). Patients will be stable and thrombocytopenic, however treatment center will intervene for bleeding. Adult hematology-oncology outpatients.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hematology-oncology; hematology-oncology outpatients requiring platelet transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLX Score Correlation with CCI	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	Patients are expected to be enrolled for an average of 6 months.

Collaborators and Investigators

• Sponsor: LightIntegra Technology
• Investigators: Principal Investigator: William A Heaton, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: platelet; transfusion; ThromboLUX; corrected count increment; thrombocytopenic
• Other Study ID Numbers: TLXPRO017