Bleeding Disorder
Conditions
Keywords
Bleeding, Hemostatics, Fibrin, Fibrinolysis, Thrombin
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.
Interventions
DIAGNOSTIC_TESTThrombin generation
Measurement of thrombin generation by ST Genesia
DIAGNOSTIC_TESTFibrinolysis
Measurement of fibrinolysis by Lysis Timer
DIAGNOSTIC_TESTFibrin clot structure
Measurement of fibrin polymerisation and permeability
DIAGNOSTIC_TESTCoated platelets
Measurement of coated platelets by flow cytometry
Sponsors
University Hospital, Geneva
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibrin clot polymerisation | At inclusion | maximal absorption (optical density) |
| Fibrin clot permeability | At inclusion | darcy coefficient (ks, cm2) |
| Fibrinolysis | At inclusion | Clot lysis time (min) |
| Thrombin generation | At inclusion | Endogenous thrombin potential (ETP, nM x min) |
| Coated platelets | At inclusion | Absolute number of coated platelets |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major bleeding episodes | Three years | Incidence of major bleeding |
| Non-major bleeding episodes | Three years | Incidence of clinically relevant non-major bleeding |
| Fibrinogen gamma' levels | At inclusion | Ratio fibrinogen gamma'/total fibrinogen (%) |
| International Society Thrombosis Hemostasis Bleeding assessment tool | three years | ISTH BAT score, 0 - 56 (high score, worse outcome) |
| Health related quality of life | three years | SF36 questionnaire, 0 - 100 (high score, better outcome) |
| Scan electron microscopy | At inclusion | Fibrin fiber diameter (nm) |
| Clot retraction | At inclusion | Ratio clot weight/serum extruded (%) |
| Plasmin generation | At inclusion | Plasmin (nM) |
| Fibrin clot formation (thrombodynamics) | At inclusion | Initial rate of clot growth (μM/min) |
Countries
Switzerland
Contacts
Primary ContactAlessandro Casini
Outcome results
None listed