Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-03-03 @ 6:40 AM
Study NCT ID:
NCT03773159
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Study Overview
Official Title:
Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
Status:
RECRUITING
Status Verified Date:
2024-04
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:
INDONESIA
Brief Summary:
Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.
An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).
The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.
Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).
An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).
The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.
Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).
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?: