ABTEST© Card Clinical Perfomance Study

Transfusion Reaction Clinical Trial

Official title:

Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140395
• Other study ID #: CPSP_20-01_V1
• Status: Completed
• Phase: N/A
• Start date: June 6, 2021
• Est. completion date: November 4, 2021

Study information

• Verified date: November 2021
• Source: Diagast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution

Description:

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 4, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Transfusion Reaction

Intervention

Diagnostic Test:
• ABTEST card
Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card

Locations

Country	Name	City	State
France	CH Arras	Arras

Sponsors (1)

Lead Sponsor	Collaborator
Diagast

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between two reagents	performance of pre transfusional controls with the referent reagent and the reagent in study	5 minutes