Back to resultsABTEST© Card Clinical Perfomance Study
Primary Purpose
Transfusion Reaction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ABTEST card
Sponsored by
About this trial
This is an interventional other trial for Transfusion Reaction focused on measuring Reagent Kits, Diagnostic
Eligibility Criteria
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.
Sites / Locations
- CH Arras
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pre transfusion control
Arm Description
Pre control transfusion with the referent reagent and the in study reagent
Outcomes
Primary Outcome Measures
Agreement between two reagents
performance of pre transfusional controls with the referent reagent and the reagent in study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05140395
Brief Title
ABTEST© Card Clinical Perfomance Study
Official Title
Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2021 (Actual)
Primary Completion Date
October 28, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diagast
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution
Detailed 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) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transfusion Reaction
Keywords
Reagent Kits, Diagnostic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
in situ used for near patient In vitro Medical device
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre transfusion control
Arm Type
Experimental
Arm Description
Pre control transfusion with the referent reagent and the in study reagent
Intervention Type
Diagnostic Test
Intervention Name(s)
ABTEST card
Intervention Description
Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card
Primary Outcome Measure Information:
Title
Agreement between two reagents
Description
performance of pre transfusional controls with the referent reagent and the reagent in study
Time Frame
5 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Huchette, phD
Organizational Affiliation
CH Arras
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Arras
City
Arras
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ABTEST© Card Clinical Perfomance Study
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