Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2023-04-01
2027-04-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients
Patients with bleeding of unknown cause
Thrombin generation
Measurement of thrombin generation by ST Genesia
Fibrinolysis
Measurement of fibrinolysis by Lysis Timer
Fibrin clot structure
Measurement of fibrin polymerisation and permeability
Coated platelets
Measurement of coated platelets by flow cytometry
Controls
Healthy voluntaries without bleeding tendency
Thrombin generation
Measurement of thrombin generation by ST Genesia
Fibrinolysis
Measurement of fibrinolysis by Lysis Timer
Fibrin clot structure
Measurement of fibrin polymerisation and permeability
Coated platelets
Measurement of coated platelets by flow cytometry
Interventions
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Thrombin generation
Measurement of thrombin generation by ST Genesia
Fibrinolysis
Measurement of fibrinolysis by Lysis Timer
Fibrin clot structure
Measurement of fibrin polymerisation and permeability
Coated platelets
Measurement of coated platelets by flow cytometry
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
16 Years
65 Years
ALL
Yes
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Casini Alessandro
Principal investigator
Principal Investigators
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Alessandro Casini
Role: PRINCIPAL_INVESTIGATOR
University Hospitals of Geneva
Locations
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Ospedale Regionale di Bellinzona
Bellinzona, , Switzerland
Inselspital - Universitätsspital Bern
Bern, , Switzerland
University Hospital
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Gruppo Ospedaliero Moncucco
Lugano, , Switzerland
Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
USZ - Universitätsspital Zürich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Eugenia Biguzzi
Role: primary
Ioannis Chanias
Role: primary
Alessandro Casini
Role: primary
Lorenzo Alberio
Role: primary
Ida Martinelli
Role: primary
Lukas Graf
Role: primary
Jan-Dirk Studt
Role: primary
Other Identifiers
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CCER 2022-02121
Identifier Type: -
Identifier Source: org_study_id