Platelet Products Tested With the ThromboLUX® Platelet Quality Test

NCT ID: NCT02158416

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Poor Platelet Transfusion Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hematology-oncology

hematology-oncology outpatients requiring platelet transfusion

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LightIntegra Technology

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William A Heaton, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

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Monter Center

New Hyde Park, New York, United States

Site Status

Countries

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United States

Other Identifiers

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TLXPRO017

Identifier Type: -

Identifier Source: org_study_id

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