RecruitingNCT05713734

Bleeding of Unknown Cause: a Swiss Case-control Study

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


Sponsor

University Hospital, Geneva

Enrollment

400 participants

Start Date

Apr 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 65 Years

Inclusion Criteria2

  • 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 Criteria12

  • 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)

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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


Locations(7)

Ospedale Regionale di Bellinzona

Bellinzona, Switzerland

Inselspital - Universitätsspital Bern

Bern, Switzerland

University Hospital

Geneva, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Gruppo Ospedaliero Moncucco

Lugano, Switzerland

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

USZ - Universitätsspital Zürich

Zurich, Switzerland

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NCT05713734


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