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Recruiting NCT05713734

Bleeding of Unknown Cause: a Swiss Case-control Study

— Observational Bleeding Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thrombin generation, Fibrinolysis, Fibrin clot structure, Coated platelets.
Who it may be relevant to
Registry conditions: Bleeding Disorder. Basic parameters: 16 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 test Thrombin generation
    Measurement of thrombin generation by ST Genesia
  • Diagnostic test Fibrinolysis
    Measurement of fibrinolysis by Lysis Timer
  • Diagnostic test Fibrin clot structure
    Measurement of fibrin polymerisation and permeability
  • Diagnostic test Coated platelets
    Measurement of coated platelets by flow cytometry

Primary outcome measures

  • Fibrin clot polymerisation [Time frame: At inclusion]
  • Fibrin clot permeability [Time frame: At inclusion]
  • Fibrinolysis [Time frame: At inclusion]
  • Thrombin generation [Time frame: At inclusion]
  • Coated platelets [Time frame: At inclusion]
Secondary outcome measures (9)
  • Fibrinogen gamma' levels [Time frame: At inclusion]
  • Scan electron microscopy [Time frame: At inclusion]
  • Clot retraction [Time frame: At inclusion]
  • Plasmin generation [Time frame: At inclusion]
  • Fibrin clot formation (thrombodynamics) [Time frame: At inclusion]
  • Major bleeding episodes [Time frame: Three years]
  • Non-major bleeding episodes [Time frame: Three years]
  • Health related quality of life [Time frame: three years]
  • International Society Thrombosis Hemostasis Bleeding assessment tool [Time frame: three years]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Switzerland · 7 centers
  • Ospedale Regionale di Bellinzona — Bellinzona
  • Inselspital - Universitätsspital Bern — Bern
  • University Hospital — Geneva
  • Centre Hospitalier Universitaire Vaudois — Lausanne
  • Gruppo Ospedaliero Moncucco — Lugano
  • Kantonsspital St.Gallen — Sankt Gallen
  • USZ - Universitätsspital Zürich — Zurich

Identifiers

NCT: NCT05713734 · CCER 2022-02121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗