Ignite Creation Date:
2024-05-06 @ 2:54 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02158416
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2014-03-17
Brief Title:
Platelet Products Tested With the ThromboLUX Platelet Quality Test
Sponsor:
LightIntegra Technology
Organization:
LightIntegra Technology
Study Overview
Official Title:
Blinded Study on Consecutive Transfusable Platelet Products Tested With the ThromboLUX Platelet Quality Test
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None