Platelet Products Tested With the ThromboLUX® Platelet Quality Test

Completed

Conditions studied: Poor Platelet Transfusion Outcome

In brief

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.

Key facts

Study ID

NCT02158416

Run by

LightIntegra Technology

People needed

116

Starts

2013-12-01

Expected to finish

2014-11-01

Last updated by the study team

2015-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult hematology-oncology outpatients
• stable and thrombocytopenic

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.