Platelet Products Tested With the ThromboLUX® Platelet Quality Test

Completed

• Conditions: Poor Platelet Transfusion Outcome

• Registration Number: NCT02158416
• Lead Sponsor: LightIntegra Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-06
• Primary Completion: 2014-07
• Study Completion: 2014-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TLX Score Correlation with CCI	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

Trial Locations

Locations (1)

Monter Center; 🇺🇸 New Hyde Park, New York, United States