Identifying causes of unexplained bleeding
Bleeding of Unknown Cause, Insight Into a Multifactorial Bleeding Disorder: a Swiss Case-control Study
This study is trying to find out what causes unexplained bleeding by looking at blood samples from patients with bleeding disorders and comparing them to healthy people over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 7 sites (Bellinzona and 6 other locations) |
| Trial ID | NCT05713734 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify specific biological patterns in patients experiencing unexplained bleeding disorders. It involves drawing blood from participants to evaluate their hemostatic profiles, which will then be compared to a control group of healthy individuals. The study will follow both patients and controls for a duration of three years to better understand the mechanisms behind the bleeding disorders.
Who should consider this trial
Good fit: Ideal candidates include men and women with specific bleeding scores indicating unexplained bleeding.
Not a fit: Patients with ongoing pregnancy, active cancer, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment options for patients with unexplained bleeding disorders.
How similar studies have performed: While there have been studies on bleeding disorders, this specific approach to identifying biological patterns in unexplained cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Man with ISTH BAT\>3. If the calculated score includes a surgical bleeding, then two other items of the score should be \>0 * Woman with ISTH BAT \>5 points. If the calculated score includes a surgical or a postpartum bleeding, then two other items of the score should be \>0 Exclusion Criteria: * Ongoing pregnancy * Intake of antithrombotic treatment or non-steroidal anti-inflammatory drugs for least 10 days at time of blood collection * Intake of antifibrinolytic or blood product administration (factor concentrate, frozen fresh plasma, prothrombin complex concentrate) for least 14 days before blood collection * Active cancer (defined as cancer diagnosis within the last five years or treatment within the two last years before study inclusion) * Active autoimmune disease * Active chronic inflammatory disease * Severe liver disease (cirrhosis \> Child A) * Renal insufficiency stage 3 * Active or recent infection (within the last 30 days) * Recent hospitalization (\<3 months) * Recent surgery (\<3 months) * Recent trauma requiring medical intervention (\<3 months)
Where this trial is running
Bellinzona and 6 other locations
- Ospedale Regionale di Bellinzona — Bellinzona, Switzerland (Recruiting)
- Inselspital - Universitätsspital Bern — Bern, Switzerland (Recruiting)
- University Hospital — Geneva, Switzerland (Recruiting)
- Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland (Recruiting)
- Gruppo Ospedaliero Moncucco — Lugano, Switzerland (Recruiting)
- Kantonsspital St.Gallen — Sankt Gallen, Switzerland (Recruiting)
- USZ - Universitätsspital Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Alessandro Casini — University Hospitals of Geneva
- Study coordinator: Alessandro Casini
- Email: alessandro.casini@hcuge.ch
- Phone: 0041223729757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.