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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with bleeding of unknown cause |
| |
| Controls | Healthy voluntaries without bleeding tendency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thrombin generation | Diagnostic Test | Measurement of thrombin generation by ST Genesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibrin clot polymerisation | maximal absorption (optical density) | At inclusion |
| Fibrin clot permeability | darcy coefficient (ks, cm2) | At inclusion |
| Fibrinolysis | Clot lysis time (min) | At inclusion |
| Thrombin generation | Endogenous thrombin potential (ETP, nM x min) | At inclusion |
| Coated platelets | Absolute number of coated platelets | At inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Fibrinogen gamma' levels | Ratio fibrinogen gamma'/total fibrinogen (%) | At inclusion |
| Scan electron microscopy | Fibrin fiber diameter (nm) |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Casini | Contact | 0041223729757 | alessandro.casini@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Casini | University Hospitals of Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Regionale di Bellinzona | Recruiting | Bellinzona | Switzerland |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D005342 | Fibrinolysis |
| ID | Term |
|---|---|
| D001777 | Blood Coagulation |
| D006487 | Hemostasis |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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Plasma and EDTA samples
| Fibrinolysis | Diagnostic Test | Measurement of fibrinolysis by Lysis Timer |
|
| Fibrin clot structure | Diagnostic Test | Measurement of fibrin polymerisation and permeability |
|
| Coated platelets | Diagnostic Test | Measurement of coated platelets by flow cytometry |
|
| At inclusion |
| Clot retraction | Ratio clot weight/serum extruded (%) | At inclusion |
| Plasmin generation | Plasmin (nM) | At inclusion |
| Fibrin clot formation (thrombodynamics) | Initial rate of clot growth (μM/min) | At inclusion |
| Major bleeding episodes | Incidence of major bleeding | Three years |
| Non-major bleeding episodes | Incidence of clinically relevant non-major bleeding | Three years |
| Health related quality of life | SF36 questionnaire, 0 - 100 (high score, better outcome) | three years |
| International Society Thrombosis Hemostasis Bleeding assessment tool | ISTH BAT score, 0 - 56 (high score, worse outcome) | three years |
| Inselspital - Universitätsspital Bern | Recruiting | Bern | Switzerland |
|
| University Hospital | Recruiting | Geneva | Switzerland |
|
| Centre Hospitalier Universitaire Vaudois | Recruiting | Lausanne | Switzerland |
|
| Gruppo Ospedaliero Moncucco | Recruiting | Lugano | Switzerland |
|
| Kantonsspital St.Gallen | Recruiting | Sankt Gallen | Switzerland |
|
| USZ - Universitätsspital Zürich | Recruiting | Zurich | Switzerland |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |