Platelet Products Tested With the ThromboLUX® Platelet Quality Test

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02158416

Enrollment

116

Registered

2014-06-06

Start date

2013-12-31

Completion date

2014-11-30

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Platelet Transfusion Outcome

Keywords

platelet, transfusion, ThromboLUX, corrected count increment, thrombocytopenic

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results