Actively Recruiting

Age: 16Years - 65Years
All Genders
Healthy Volunteers
ID05713734

Bleeding of Unknown Cause, Insight Into a Multifactorial Bleeding Disorder: a Swiss Case-control Study

Led by University Hospital, Geneva · Updated on 2026-04-29

400

Participants Needed

7

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to identify specific biological patterns in patients who experience bleeding of unknown cause and to study the underlying mechanisms for each patient group. It is a prospective cohort study comparing these patients to a control group of healthy individuals without bleeding tendencies. The study is being conducted by the University Hospital in Geneva and spans over several years to gain insight into this complex bleeding disorder. Participants include patients with unexplained bleeding and healthy volunteers as controls. At the start, blood samples are taken from all participants to evaluate various aspects of blood clotting, such as fibrin clot polymerization, permeability, fibrinolysis, thrombin generation, and platelet coating. These diagnostic tests help researchers analyze the differences between patients and controls. The study follows participants for three years to observe bleeding episodes and other health outcomes. During the study, participants will undergo several assessments including blood tests, quality of life questionnaires, and bleeding evaluations using recognized tools like the ISTH bleeding assessment tool. Researchers will monitor major and non-major bleeding episodes over three years. The study also collects detailed laboratory data at inclusion, such as fibrinogen levels and clot structure imaging. This comprehensive follow-up helps researchers understand the natural course and impact of bleeding disorders over time.

CONDITIONS

Brief Title

Bleeding of Unknown Cause: a Swiss Case-control Study

Who Can Participate

Age: 16Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Man with ISTH BAT >3; if the score includes surgical bleeding, then two other items should be >0
  • Woman with ISTH BAT >5; if the score includes surgical or postpartum bleeding, then two other items should be >0
  • Age between 16 and 65 years
  • Patients with bleeding of unknown cause
  • Healthy volunteers without bleeding tendency
Not Eligible

You will not qualify if you...

  • Ongoing pregnancy
  • Intake of antithrombotic treatment or non-steroidal anti-inflammatory drugs for at least 10 days at time of blood collection
  • Intake of antifibrinolytic or blood product administration for at least 14 days before blood collection
  • Active cancer diagnosed within last 5 years or treated within last 2 years
  • Active autoimmune disease
  • Active chronic inflammatory disease
  • Severe liver disease (cirrhosis > Child A)
  • Renal insufficiency stage 3
  • Active or recent infection within last 30 days
  • Recent hospitalization within last 3 months
  • Recent surgery within last 3 months
  • Recent trauma requiring medical intervention within last 3 months

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants have blood drawn at baseline to evaluate their hemostatic profile through various diagnostic tests.

1 baseline visit (in-person)

Long-term Monitoring

Duration - 3 years

Participants are followed for 3 years to observe bleeding episodes and assess quality of life.

Periodic follow-up visits during 3 years

Trial Site Locations

Total: 7 locations

1

Ospedale Regionale di Bellinzona

Bellinzona, Switzerland

Actively Recruiting

2

Inselspital - Universitätsspital Bern

Bern, Switzerland

Actively Recruiting

3

University Hospital

Geneva, Switzerland

Actively Recruiting

4

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Actively Recruiting

5

Gruppo Ospedaliero Moncucco

Lugano, Switzerland

Actively Recruiting

6

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Actively Recruiting

7

USZ - Universitätsspital Zürich

Zurich, Switzerland

Actively Recruiting

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Research Team

A

Alessandro Casini

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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