Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions

What this Trial Is About

Researchers are evaluating a new device designed to test primary hemostasis, which is the body's natural process to stop bleeding. Current tests for bleeding risk focus on platelets or von Willebrand factor but do not fully mimic real blood flow or include the role of all blood cells. This study aims to assess the performance of this new test using whole blood under conditions similar to blood vessels with different flow types, which may help better identify bleeding risks in patients with von Willebrand factor deficiency or those on antiplatelet therapy. The study involves collecting a small amount of blood—up to four citrated tubes and one EDTA tube—either during routine blood draws for patients or blood donation for healthy controls. Participants include patients with von Willebrand disease, major constitutional thrombopathy, or those taking antiplatelet drugs, as well as healthy blood donors. The device will be tested under venous and arterial flow conditions to evaluate how well it replicates physiological blood clotting. Participants provide blood samples once, which are then analyzed using the new device. Researchers will measure the repeatability and reproducibility of the test results in healthy controls and its ability to detect bleeding issues related to antiplatelet therapy or von Willebrand factor deficiency. The study is observational and aims to improve understanding of bleeding risk assessment. Participation involves only blood collection alongside routine tests or donation, with no additional procedures required.

Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions