Bleeding of Unknown Cause: a Swiss Case-control Study (SWISS-BUC)

University Hospitals (UH)

Status

Enrolling

Conditions

Bleeding Disorder

Treatments

Diagnostic Test: Fibrinolysis

Diagnostic Test: Thrombin generation

Diagnostic Test: Coated platelets

Diagnostic Test: Fibrin clot structure

Study type

Observational

Funder types

Other

Identifiers

NCT05713734

CCER 2022-02121

Details and patient eligibility

About

The goal of this prospective cohort is to identified specific biological patterns in patients with a bleeding of unknown cause and to study the specific mechanisms of the bleeding disorder for each subset of patients.

Full description

Patients with bleeding of unknown cause are included. At baseline, blood will be drawn to evaluate the hemostatic profile. Findings are compared to a control group of healthy individuals. Patients and controls are followed for 3 years.

Enrollment

400 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)