Bleeding of Unknown Cause: a Swiss Case-control Study

Bleeding Disorder Clinical Trial

— SWISS-BUC  

Official title:

Bleeding of Unknown Cause, Insight Into a Multifactorial Bleeding Disorder: a Swiss Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713734
• Other study ID #: CCER 2022-02121
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2023
• Source: University Hospital, Geneva
• Contact: Alessandro Casini
• Phone: 0041223729757
• Email: alessandro.casini[@]hcuge.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Switzerland	University Hospital	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrin clot polymerisation	maximal absorption (optical density)	At inclusion
Primary	Fibrin clot permeability	darcy coefficient (ks, cm2)	At inclusion
Primary	Fibrinolysis	Clot lysis time (min)	At inclusion
Primary	Thrombin generation	Endogenous thrombin potential (ETP, nM x min)	At inclusion
Primary	Coated platelets	Absolute number of coated platelets	At inclusion
Secondary	Fibrinogen gamma' levels	Ratio fibrinogen gamma'/total fibrinogen (%)	At inclusion
Secondary	Scan electron microscopy	Fibrin fiber diameter (nm)	At inclusion
Secondary	Clot retraction	Ratio clot weight/serum extruded (%)	At inclusion
Secondary	Plasmin generation	Plasmin (nM)	At inclusion
Secondary	Fibrin clot formation (thrombodynamics)	Initial rate of clot growth (µM/min)	At inclusion
Secondary	Major bleeding episodes	Incidence of major bleeding	Three years
Secondary	Non-major bleeding episodes	Incidence of clinically relevant non-major bleeding	Three years
Secondary	Health related quality of life	SF36 questionnaire, 0 - 100 (high score, better outcome)	three years
Secondary	International Society Thrombosis Hemostasis Bleeding assessment tool	ISTH BAT score, 0 - 56 (high score, worse outcome)	three years