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Bleeding Disorder of Unknown Cause in the Netherlands

Recruitingn/aAges 12 Years - anyAllMaastricht University Medical Center
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In plain words

What the trial is, and whether it could suit you

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 a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ 5 in women age 18-30; โ‰ฅ 6 in women age 31-51, โ‰ฅ 7 in women age 52 or older; โ‰ฅ4 in men and โ‰ฅ 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
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What it tests

  • Not listed
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Where

8 sites
Radboud University Medical Center
Nijmegen, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Maxima Medical Center
Veldhoven, Netherlands
Amsterdam University Medical Center
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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