Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868214
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2021-03-30
Brief Title:
Multi-site Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants and Verification of Measurement Precision of Liquid Quality Controls With the Perosphere Technologies PoC Coagulometer
Sponsor:
Sciema UG
Organization:
Sciema UG
Study Overview
Official Title:
Multi-site Study for Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants and Verification of Measurement Precision of Liquid Quality Controls With the Perosphere Technologies PoC Coagulometer
Status:
RECRUITING
Status Verified Date:
2023-09
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:
The Perosphere Technologies PoC Coagulometer measures clotting times of fresh whole blood samples Clotting is initiated by glass surface activation and terminates on optical detection of fibrin assembly the final step in the coagulation cascade Since activation occurs at the top of the intrinsic pathway and detection occurs at the bottom of the final common pathway the Perosphere Technologies PoC Coagulometer has shown sensitivity to a broad range of drugs and reagents that affect blood clotting processes including the Direct Oral Anticoagulants DOACs eg rivaroxaban apixaban and edoxaban as well as the heparins eg enoxaparin a low molecular weight heparin and unfractionated heparin The purpose of the present study is to characterize the performance of the PoC Coagulometer measuring Clotting Time Controls as well as fresh whole blood from both healthy volunteers and DOAC patients at three field testing sites
Detailed Description:
None
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