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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
Eligibility Criteria
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
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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have blood drawn at baseline to evaluate their hemostatic profile through various diagnostic tests.
1 baseline visit (in-person)
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
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2
Inselspital - Universitätsspital Bern
Bern, Switzerland
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3
University Hospital
Geneva, Switzerland
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4
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
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5
Gruppo Ospedaliero Moncucco
Lugano, Switzerland
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6
Kantonsspital St.Gallen
Sankt Gallen, Switzerland
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7
USZ - Universitätsspital Zürich
Zurich, Switzerland
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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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