Unexplained bleeding disorders in the Netherlands

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• Maastricht University Medical Center
  Maastricht, Limburg, Netherlands Recruiting
• Radboud University Medical Center
  Nijmegen, Gelderland, Netherlands Not yet 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.