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Why do they bleed? dutch study seeks answers for mystery bleeding disorder

NCT ID NCT07454161

Knowledge-focused Sponsor: Maastricht University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to understand why some people have unexplained bleeding that standard tests cannot diagnose. Researchers will study blood samples and ask participants about their symptoms and quality of life. The goal is to find the causes of this bleeding disorder and improve care for those affected. About 500 people in the Netherlands will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2039

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals aged ≥12 years with a clinically relevant increased bleeding tendency, based on an elevated ISTH Bleeding Assessment Tool (ISTH-BAT) score or the clinical view of a (pediatric) hemostasis specialist, who remain undiagnosed following comprehensive laboratory investigation and are consequently classified as having a bleeding disorder of unknown cause (BDUC), will be identified at one of the six Hemophilia treatment centers in the Netherlands and approached for study participation by their treating physician.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

disease hemorrhagic disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bleeding disorder of unknown cause Hemorrhagic disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam University Medical Center

    NOT_YET_RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Erasmus Medisch Centrum

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Leiden University Medical Center

    NOT_YET_RECRUITING

    Leiden, South Holland, 2333 ZA, Netherlands

  • Maastricht University Medical Center

    RECRUITING

    Maastricht, Limburg, 6228 HX, Netherlands

  • Maxima Medical Center

    NOT_YET_RECRUITING

    Veldhoven, North Brabant, 5504 DB, Netherlands

  • Radboud University Medical Center

    NOT_YET_RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • University Medical Center Groningen

    NOT_YET_RECRUITING

    Groningen, Provincie Groningen, 971 GZ, Netherlands

  • University Medical Center Utrecht

    NOT_YET_RECRUITING

    Utrecht, Utrecht, 3584 CX, Netherlands

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