Actively Recruiting
Bleeding Disorder of Unknown Cause in the Netherlands
Led by Maastricht University Medical Center · Updated on 2026-04-27
500
Participants Needed
8
Research Sites
669 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
S
Sanquin Research & Blood Bank Divisions
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bleeding Disorder of Unknown Cause in the Netherlands
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Referred to a (pediatric) hemostasis specialist for evaluation of bleeding tendency.
- Increased bleeding tendency based on abnormal 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; ≥3 in children) or clinical assessment by physician.
- No diagnosis of bleeding disorder based on standard lab tests including hemoglobin > 6.0 mmol/L, platelet count > 100 x10^9/L.
- Normal or non-explanatory abnormalities in PT, aPTT, fibrinogen activity, VWF antigen & activity, factor VIII, IX, XI, XIII.
- Light transmission aggregometry not diagnostic for platelet function disorder.
- Kidney function eGFR > 45 ml/min.
- Liver function tests (ALAT, bilirubin) less than 3 times upper normal limit.
You will not qualify if you...
- Use of medication affecting hemostasis tests that cannot be stopped before blood sampling.
- Pregnancy or lactation at time of inclusion.
- Presence of an established bleeding disorder.
- Presence of acquired cause or other explanation for increased bleeding.
- Inability to provide informed consent.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA
Not Yet Recruiting
2
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6228 HX
Actively Recruiting
3
Maxima Medical Center
Veldhoven, North Brabant, Netherlands, 5504 DB
Not Yet Recruiting
4
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1105 AZ
Not Yet Recruiting
5
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 971 GZ
Not Yet Recruiting
6
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Not Yet Recruiting
7
Erasmus Medisch Centrum
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
8
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX
Not Yet Recruiting
Research Team
D
Dr. F.C.J.I. Heubel-Moenen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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