NCT05140395

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
Last Updated

December 1, 2021

Status Verified

November 1, 2021

Enrollment Period

5 months

First QC Date

November 19, 2021

Last Update Submit

November 19, 2021

Conditions

Transfusion Reaction

Keywords

Reagent Kits, Diagnostic

Outcome Measures

Primary Outcomes (1)

  • Agreement between two reagents

    performance of pre transfusional controls with the referent reagent and the reagent in study

    5 minutes

Study Arms (1)

Pre transfusion control

EXPERIMENTAL

Pre control transfusion with the referent reagent and the in study reagent

Diagnostic Test: ABTEST card

Interventions

ABTEST cardDIAGNOSTIC_TEST

Pre transfusional control with the referent ABTEST card and the in study ABDTEST Card

Pre transfusion control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

CH Arras

Arras, France

Location

MeSH Terms

Conditions

Transfusion ReactionDisease

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pascal Huchette, phD

    CH Arras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: in situ used for near patient In vitro Medical device
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2021

First Posted

December 1, 2021

Study Start

June 6, 2021

Primary Completion

October 28, 2021

Study Completion

November 4, 2021

Last Updated

December 1, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)