Unexplained bleeding disorders in the Netherlands
Bleeding Disorder of Unknown Cause In the Netherlands (BDUC-iN Study)
Maastricht University Medical Center · NCT07454161
This project will try to find blood-based and genetic reasons for unexplained bleeding in people referred to hemostasis centers in the Netherlands.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center (other) |
| Locations | 8 sites (Nijmegen, Gelderland and 7 other locations) |
| Trial ID | NCT07454161 on ClinicalTrials.gov |
What this trial studies
Adults and children with an increased bleeding tendency who remain undiagnosed after standard coagulation testing are enrolled at specialized Dutch hemostasis centers. Participants provide blood samples for extended hemostasis testing and genetic analysis and complete validated patient-reported outcome questionnaires about bleeding impact and quality of life. The study also documents how care is currently delivered to these patients to identify gaps and opportunities for better management. Results aim to improve diagnostic accuracy and inform more tailored treatment and care pathways for people with bleeding disorder of unknown cause (BDUC).
Who should consider this trial
Good fit: People referred to a (pediatric) hemostasis specialist with an abnormal ISTH-BAT score or clinical bleeding concern who have normal or non-explanatory standard coagulation test results are ideal candidates.
Not a fit: Patients who already have a clear laboratory diagnosis (for example, von Willebrand disease or a known platelet function disorder) or whose bleeding is explained by non-hemostatic causes are unlikely to gain benefit from this study.
Why it matters
Potential benefit: If successful, the study could lead to clearer diagnoses and more targeted treatment plans that reduce bleeding and improve daily functioning and quality of life.
How similar studies have performed: Previous research has shown that extended hemostasis testing and genetic analyses can identify causes in some previously unexplained cases, but a substantial proportion of BDUC cases remain without a clear etiology.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nijmegen, Gelderland and 7 other locations
- Radboud University Medical Center — Nijmegen, Gelderland, Netherlands (NOT_YET_RECRUITING)
- Maastricht University Medical Center — Maastricht, Limburg, Netherlands (RECRUITING)
- Maxima Medical Center — Veldhoven, North Brabant, Netherlands (NOT_YET_RECRUITING)
- Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (NOT_YET_RECRUITING)
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (NOT_YET_RECRUITING)
- Leiden University Medical Center — Leiden, South Holland, Netherlands (NOT_YET_RECRUITING)
- Erasmus Medisch Centrum — Rotterdam, South Holland, Netherlands (NOT_YET_RECRUITING)
- University Medical Center Utrecht — Utrecht, Utrecht, Netherlands (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: F.C.J.I. Heubel-Moenen, Dr. — Maastricht University Medical Center
- Study coordinator: Dr. F.C.J.I. Heubel-Moenen
- Email: floor.moenen@mumc.nl
- Phone: +31 (0)43 3876543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemorrhagic Disorders, Bleeding Disorder of Unknown Cause, Bleeding disorder of unknown cause, Hemostasis, Diagnosis, Management, Pathofysiology, Quality of life