NCT07454161 Bleeding Disorder of Unknown Cause in the Netherlands
| NCT ID | NCT07454161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maastricht University Medical Center |
| Condition | Hemorrhagic Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2039-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-05-01 with a primary completion date of 2039-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 * Absence of diagnostic test results for a bleeding disorder in standard laboratory hemostasis tests: * 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 * Fibrinogen activity, von Willebrand Factor (VWF) antigen \& activity, Factor VIII, IX, XI and XIII: within local reference range or abnormal but not explaining bleeding phenotype * Light transmission aggregometry (LTA): Not diagnostic for a platelet function * Kidney function: eGFR \> 45 ml/min * Liver function: ALAT, bilirubin \< 3 x upper limit of normal Exclusion Criteria: * 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 * Inability to provide informed consent
Contact & Investigator
F.C.J.I. Heubel-Moenen, Dr.
PRINCIPAL INVESTIGATOR
Maastricht University Medical Center
Frequently Asked Questions
Who can join the NCT07454161 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Hemorrhagic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07454161 currently recruiting?
Yes, NCT07454161 is actively recruiting participants. Contact the research team at floor.moenen@mumc.nl for enrollment information.
Where is the NCT07454161 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Maastricht, Netherlands, Veldhoven, Netherlands, Amsterdam, Netherlands and 4 additional locations.
Who is sponsoring the NCT07454161 clinical trial?
NCT07454161 is sponsored by Maastricht University Medical Center. The principal investigator is F.C.J.I. Heubel-Moenen, Dr. at Maastricht University Medical Center. The trial plans to enroll 500 participants.