Bleeding Disorder of Unknown Cause in the Netherlands
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorMaastricht University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Referred to a (pediatric) hemostasis specialist for evaluation of bleeding tendency.
Increased bleeding tendency based on: Abnormal International Society on Thrombosis and Haemostasis Bleeding Assessment Tool (ISTH-BAT) score (≥ 5 in women age 18-30; ≥ 6 in women age 31-51, ≥ 7 in women age 52 or older; ≥4 in men and ≥ 3 in children) OR Clinical gestalt according to the investigating physician
Complete blood count: Hemoglobin > 6.0 mmol/L; thrombocyte count > 100 x10^9/L
Prothrombin (PT) and activated Partial Thromboplastin Time (aPTT): within local reference range, or prolonged without explanatory factor deficiency
Disqualifiers
Use of medication interfering with laboratory hemostasis tests which cannot be stopped before blood withdrawal
Pregnancy or lactation at moment of inclusion
Presence of an established bleeding disorder
Presence of an acquired cause or another explanation for the increased bleeding tendency
Trial design
Treatments tested in this trial
- Not listed
Trial groups
500 Participants
are grouped into 1 trial groupSponsors and collaborators
Maastricht University Medical Center
Lead sponsor
Sanquin Research & Blood Bank Divisions
Collaborator
Source ClinicalTrials.gov