Bleeding of Unknown Cause, Insight Into a Multifactorial Bleeding Disorder: a Swiss Case-control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Geneva
- Enrollment
- 400
- Locations
- 7
- Primary Endpoint
- Fibrin clot polymerisation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Man with ISTH BAT>
- •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)
Outcomes
Primary Outcomes
Fibrin clot polymerisation
Time Frame: At inclusion
maximal absorption (optical density)
Fibrin clot permeability
Time Frame: At inclusion
darcy coefficient (ks, cm2)
Fibrinolysis
Time Frame: At inclusion
Clot lysis time (min)
Thrombin generation
Time Frame: At inclusion
Endogenous thrombin potential (ETP, nM x min)
Coated platelets
Time Frame: At inclusion
Absolute number of coated platelets
Secondary Outcomes
- Fibrinogen gamma' levels(At inclusion)
- Clot retraction(At inclusion)
- Major bleeding episodes(Three years)
- Scan electron microscopy(At inclusion)
- Non-major bleeding episodes(Three years)
- Health related quality of life(three years)
- International Society Thrombosis Hemostasis Bleeding assessment tool(three years)
- Plasmin generation(At inclusion)
- Fibrin clot formation (thrombodynamics)(At inclusion)
Investigators
Casini Alessandro
Principal investigator
University Hospital, Geneva