Ignite Creation Date:
2024-05-06 @ 12:57 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03890146
Status:
TERMINATED
Last Update Posted:
2021-01-29
First Post:
2019-02-18
Brief Title:
Concordance of Capillary Blood Biological Samples With Conventional Venousbiological Blood Samples
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
we submitted an amendment The study was stopped because this amendment raised the complexity of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPIVEIN
Brief Summary:
The main objectives are to evaluate the concordance between the results of natremia kalaemia and blood sugar levels obtained 1 by capillary puncture analysed on a delocalized resuscitation machine GEM 4000 Werfen and 2 by venous sampling analysed on the machine of the standard biology laboratory Gen 2 COBAS Roche
Detailed Description:
The completion of a biological test suits a succession of codified steps
Medical prescription
The pre-analytic phase preparation of the material completion of the sample transport of the sample and preparation of it
The analytical phase
The post-analytic phase validation of the result obtained and the dissemination of it to the prescriber usually the clinician who is then able to make a medical decision This succession of steps involves as part of a classical journey many stakeholders doctors nurses couriers laboratory technicians medical biologists in different places
Outsourced biology care test point POCT refers to the analysis of biological samples outside the central laboratory The sample is most often carried out transported and analyzed by the same person on a machine near the patient or in the service and therefore in the absence of direct control of a specialized laboratory technician or a medical biologist who remains however responsible for good practice maintenance of the device and validity of the results
The completion of biological examinations is regulated by differents Articles The outsourced biology ADBD sampling analysis can be carried out in the hospital in most departments and also outside the hospital pharmacies city offices or even in the patients own home On portable devices usually highly specialized and these fixed allowing a greater diversity of tests
Its development is booming with annual growth estimated in 2006 at 155 in the United States
Medical prescription
The pre-analytic phase preparation of the material completion of the sample transport of the sample and preparation of it
The analytical phase
The post-analytic phase validation of the result obtained and the dissemination of it to the prescriber usually the clinician who is then able to make a medical decision This succession of steps involves as part of a classical journey many stakeholders doctors nurses couriers laboratory technicians medical biologists in different places
Outsourced biology care test point POCT refers to the analysis of biological samples outside the central laboratory The sample is most often carried out transported and analyzed by the same person on a machine near the patient or in the service and therefore in the absence of direct control of a specialized laboratory technician or a medical biologist who remains however responsible for good practice maintenance of the device and validity of the results
The completion of biological examinations is regulated by differents Articles The outsourced biology ADBD sampling analysis can be carried out in the hospital in most departments and also outside the hospital pharmacies city offices or even in the patients own home On portable devices usually highly specialized and these fixed allowing a greater diversity of tests
Its development is booming with annual growth estimated in 2006 at 155 in the United States
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None