Clinical trial NCT05713734: Bleeding of Unknown Cause: a Swiss Case-control Study
Official title: Bleeding of Unknown Cause, Insight Into a Multifactorial Bleeding Disorder: a Swiss Case-control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bleeding Disorder
Keywords: Bleeding
Hemostatics
Fibrin
Fibrinolysis
Thrombin
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women and men aged 16-65 years who have been diagnosed as patients with bleeding of unknown cause Women and men aged 16-65 years without bleeding tendency

Brief summary: 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Fibrin clot polymerisation
timeFrame: At inclusion
measure: Fibrin clot permeability
timeFrame: At inclusion
measure: Fibrinolysis
timeFrame: At inclusion
measure: Thrombin generation
timeFrame: At inclusion
measure: Coated platelets
timeFrame: At inclusion
Secondary outcomes:
measure: Fibrinogen gamma' levels
timeFrame: At inclusion
measure: Scan electron microscopy
timeFrame: At inclusion
measure: Clot retraction
timeFrame: At inclusion
measure: Plasmin generation
timeFrame: At inclusion
measure: Fibrin clot formation (thrombodynamics)
timeFrame: At inclusion
measure: Major bleeding episodes
timeFrame: Three years
measure: Non-major bleeding episodes
timeFrame: Three years
measure: Health related quality of life
timeFrame: three years
measure: International Society Thrombosis Hemostasis Bleeding assessment tool
timeFrame: three years
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale di Bellinzona
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Geneva
country: Switzerland
facility: University Hospital
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Lugano
country: Switzerland
facility: Gruppo Ospedaliero Moncucco
city: St Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Zurich
country: Switzerland
facility: USZ - Universitätsspital Zürich
Study officials:
affiliation: University Hospitals of Geneva
name: Alessandro Casini
role: PRINCIPAL_INVESTIGATOR
References: