Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04458155
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2020-06-30
Brief Title:
Li-Hep vs Non-Li-Hep Coated Transfer Device
Sponsor:
VieCuri Medical Centre
Organization:
VieCuri Medical Centre
Study Overview
Official Title:
Sample Comparison With Siemens Point-of-care Device for Cardiac Troponin I Assay by Using a Heparin Coated Transfer Device vs Non-heparin Coated Transfer Device at the Emergency Department Validation Study 20
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective diagnostic cohort study within the standard care of acute coronary syndrome ACS patients It compares the analytical performance of Siemens point-of-care high sensitive troponin I testing in venous plasma and capillary sample types The investigators hypothesize that there is a good correlation between the Siemens POC HS cTnI assay results for the three sample types and that the bias between different POC sample types reduces from 10 to 5 when using heparinized transfer device for the capillary sample
Detailed Description:
In September 2019 the validation study 10 started in which the cTnI result of the Siemens POC device on three sample types are compared Interim analysis of the sample comparison was performed by regression analysis using Passing and Bablock and calculating the Pearson correlation coefficient
The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 100-103 with an R of 099 so the results between these sample types can be used interchangeably For the capillary sample vs the Li-hep sample both blood and plasma the slope is 8-12 higher With a 8-12 higher response the capillary test results may not be interchangeably used with the other 2 sample types
It is remarkable that capillary samples give a higher response since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid The investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device this hypothesis will be tested
The Li-hep Plasma vs Li-hep venous blood show a very good correlation of 100-103 with an R of 099 so the results between these sample types can be used interchangeably For the capillary sample vs the Li-hep sample both blood and plasma the slope is 8-12 higher With a 8-12 higher response the capillary test results may not be interchangeably used with the other 2 sample types
It is remarkable that capillary samples give a higher response since it was anticipated that the result may be slightly lower due to the possible dilution by interstitial fluid The investigators hypothesize that the presence of the Li-heparin anti-coagulant in the venous draw lead to a slight reduction of the apparent cTnI concentration By using a heparin coated transfer device for the capillary samples instead of an uncoated transfer device this hypothesis will be tested
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| METCZ20200008 | OTHER | None | None |
| NL7244509620 | OTHER | ToetsingOnline IDCCMO ID | None |