Bleeding of Unknown Cause: a Swiss Case-control Study

NCT05713734 | Recruiting

• 1 other identifier: CCER 2022-02121
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 7

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.

Conditions

Bleeding Disorder

Keywords

Bleeding; Hemostatics; Fibrin; Fibrinolysis; Thrombin

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (9)

• Fibrinogen gamma' levels

  At inclusion

• Scan electron microscopy

  At inclusion

• Clot retraction

  At inclusion

• Plasmin generation

  At inclusion

• Fibrin clot formation (thrombodynamics)

  At inclusion

Study Arms (2)

Patients

Patients with bleeding of unknown cause

Diagnostic Test: Thrombin generation; Diagnostic Test: Fibrinolysis; Diagnostic Test: Fibrin clot structure; Diagnostic Test: Coated platelets

Controls

Healthy voluntaries without bleeding tendency

Diagnostic Test: Thrombin generation; Diagnostic Test: Fibrinolysis; Diagnostic Test: Fibrin clot structure; Diagnostic Test: Coated platelets

Interventions

Thrombin generation DIAGNOSTIC_TEST

Measurement of thrombin generation by ST Genesia

Controls; Patients

Fibrinolysis DIAGNOSTIC_TEST

Measurement of fibrinolysis by Lysis Timer

Controls; Patients

Fibrin clot structure DIAGNOSTIC_TEST

Measurement of fibrin polymerisation and permeability

Controls; Patients

Coated platelets DIAGNOSTIC_TEST

Measurement of coated platelets by flow cytometry

Controls; Patients

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (7)

Ospedale Regionale di Bellinzona

Bellinzona, Switzerland

RECRUITING

Inselspital - Universitätsspital Bern

Bern, Switzerland

RECRUITING

University Hospital

Geneva, Switzerland

RECRUITING

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

RECRUITING

Gruppo Ospedaliero Moncucco

Lugano, Switzerland

RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

RECRUITING

USZ - Universitätsspital Zürich

Zurich, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and EDTA samples

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage

Interventions

Fibrinolysis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Coagulation; Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Alessandro Casini

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Casini

CONTACT

0041223729757; alessandro.casini@hcuge.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CH (7)