Clinical Trial

Bleeding Disorder of Unknown Cause in the Netherlands

Study acronym: BDUC-iN
Recruiting
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Summary
The purpose of the Bleeding Disorder of Unknown Cause in the Netherlands study (BDUC-iN) is to learn more about unexplained bleeding in individuals with a bleeding disorder of unknown cause (BDUC). The study aims to better understand why these individuals have increased bleeding and how it affects their health and daily life. The main questions of this study are: 1. What are the mechanisms underlying the bleeding tendency in BDUC? 2. How do bleeding symptoms affect patients' daily functioning and overall health-related quality of life? 3. How is care delivered to individuals with BDUC, and how can this be improved? Participants with increased bleeding tendency who remain undiagnosed after standard coagulation testing and are consequently classified as having BDUC will be enrolled across the Hemophilia treatment centers in the Netherlands. Participants will undergo blood sampling for advanced hemostasis testing and genetic analysis. In addition, participants will complete validated questionnaires to assess bleeding symptoms and health-related quality of life. Participants will be followed longitudinally to evaluate how bleeding symptoms affect daily activities, medical procedures, and overall health-related quality of life.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-04-28
critical Primary endpoint(s) modified 2026-04-28
Trial Details
NCT Number NCT07454161
Lead Sponsor Maastricht University Medical Center
Collaborators: Sanquin Research & Blood Bank Divisions
Conditions Hemorrhagic Disorders, Bleeding Disorder of Unknown Cause
Enrollment 500 participants
Start Date 2026-05-01
Primary Completion 2039-03-01 (estimated)
Study Completion 2039-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-27