An interventional study of ABTEST card in Transfusion Reaction, sponsored by Diagast. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by Diagast · Not applicable, Interventional, and Other
The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution
The study consists to perform on 100 patients a first pre transfusional control with the reference in vitro reagent ABTEST card (CE Marked reagent) followed by a another pre transfusional control with the in vitro reagent ABTEST card in study (new reformulated WS solution used) .
50 studies on the registry are indexed under Transfusion Reaction; 11 are open to participants now.
This study's enrollment of 100 is above the median of 76 across 20 interventional studies indexed under Transfusion Reaction.
Browse Transfusion Reaction studies →Diagast is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
66 patients in hematology / oncology departments , including 20 patients with a hemoglobin significantly below the norm (\<8g / dl hemoglobin in the blood), and about to receive a transfusion. 20 patients hospitalized in gastroenterology with a transfusion need 4 internal medicine patients with cold agglutinins, in a transfusion context or not.
10 neonatal patients, background transfusion or Guthrie test.
Pre control transfusion with the referent reagent and the in study reagent
Diagnostic Test: ABTEST card
Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card
Agreement between two reagents
performance of pre transfusional controls with the referent reagent and the reagent in study
Time frame: 5 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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