Diagnostic in Vitro Method for Assessing von Willebrand Disease and Increased Bleeding Risk Associated with von Willebrand Disease and Acquired or Congenital Disorders of Platelet Function

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This invention describes a rapid, in-vitro diagnostic method for assessing von Willebrand Disease (VWD) and increased bleeding risks caused by VWD and various platelet function disorders. The method measures how blood clots and changes its viscoelasticity after the addition of a substance (such as ristocetin) that triggers platelet aggregation, using techniques like thromboelastography. By comparing test results with and without the activator, the method can quickly identify deficiencies in von Willebrand factor (VWF) or defects in platelet function that increase bleeding risk. The test can be performed at the point of care, requires only a small blood sample, and provides fast, reliable results.

Use CasesContent extracted from patent full text and abstract with AI.

• Preoperative screening to assess bleeding risk in patients before surgery.
• Routine diagnosis of von Willebrand Disease and various acquired or congenital platelet function disorders in clinical laboratories.
• Bedside (point-of-care) bleeding risk assessment for trauma patients or in emergency settings.
• Monitoring and adjusting therapy (e.g., DDAVP or VWF concentrate) for patients with bleeding disorders.
• Rapid screening of newborns, children, or adults for inherited or acquired bleeding tendencies.
• Distinguishing between different types or causes of bleeding disorders, including VWD subtypes, platelet storage pool disease, and dysfibrinogenemia.
• General screening for coagulopathies in patients with unexplained bleeding symptoms.

BenefitsContent extracted from patent full text and abstract with AI.

• Provides rapid results, enabling timely medical decisions, especially before surgery or during emergencies.
• Requires only a very small blood volume, advantageous for pediatric or neonatal testing.
• Can be performed as a point-of-care test, minimizing delay and sample transport issues.
• Eliminates the need for complex and time-consuming laboratory workflows (e.g., VWF multimer analysis, ELISA).
• Sensitive to both qualitative and quantitative VWF defects and platelet function abnormalities, improving diagnostic accuracy.
• Reduces false positives and negatives compared to traditional assay methods, especially in challenging cases or subtypes.
• Allows simultaneous assessment and differential diagnosis of multiple bleeding disorders in a single assay.
• Supports monitoring of therapeutic interventions to guide and evaluate treatment efficacy in real time.

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Patent Abstract

The invention relates to an in-vitro method for diagnosing Von Willebrand Disease (VWD) and an increased bleeding risk associated with von Willebrand Disease and/or acquired or congenital platelet function defects which reduce the interaction of von Willebrand Factor (VWF) with platelets. The in-vitro method of the invention may also be used to diagnose further bleeding risks. The test is suitable for use as a screening test based on whole blood and has the additional benefit of being suitable as a point of care test. The method involves the incubation of a sample containing platelets and haemostasis factors with an activator of platelet aggregation and the measurement of the viscoelastic change after inducing coagulation, e.g. by means of thromboelastography (TEG).