Observational studyResearch and practice in thrombosis and haemostasis2026
A multicenter prospective observational cohort study to improve diagnostic yield and clinical management of persons with a Bleeding Disorder of Unknown Cause (BDUC-iN study protocol).
Observational study in Research and practice in thrombosis and haemostasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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20 authors.
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Abstract
Background: In half of individuals referred for evaluation of bleeding symptoms, no hemostatic defect is identified with current standard hemostasis tests. These individuals are classified as having a bleeding disorder of unknown cause (BDUC). The pathophysiological mechanisms underlying the bleeding tendency in BDUC are unknown. The absence of a clear, molecular diagnosis leads to significant challenges for healthcare professionals in terms of diagnostics and clinical management, as well as insecurity in patients and caregivers. Objectives: The BDUC in the Netherlands (BDUC-iN) study aims to improve diagnostic accuracy and optimize treatment strategies among individuals with BDUC by evaluating healthcare delivery, patient outcomes, health-related quality of life and by identifying underlying pathophysiological mechanisms of the bleeding tendency. Methods: This is a multicenter prospective observational cohort study aiming to include 500 persons with BDUC. Diagnostic, therapeutic and fundamental research questions are organized in dedicated work packages. Conclusions: Clinical data is collected longitudinally over a 10-year follow-up period. Quality of life and quality of care are assessed using validated questionnaires. Advanced hemostasis tests and proteogenomics are performed to characterize bleeding phenotypes and potentially identify hemostatic defects.Conclusions: The BDUC-iN study applies a structured approach to address current challenges in BDUC. It aims to improve clinical management and patient outcomes by attaining diagnostic accuracy and developing pathophysiologically-based treatment strategies. In turn, this will support the development of (evidence-based) clinical guidelines and shape future research initiatives in BDUC.
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