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NCT Number: NCT05713734

Bleeding of Unknown Cause: a Swiss Case-control Study

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.

Recruiting

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Regionale di Bellinzona, Bellinzona, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Thrombin generation

Diagnostic Test

Measurement of thrombin generation by ST Genesia

Fibrinolysis

Diagnostic Test

Measurement of fibrinolysis by Lysis Timer

Fibrin clot structure

Diagnostic Test

Measurement of fibrin polymerisation and permeability

Coated platelets

Diagnostic Test

Measurement of coated platelets by flow cytometry

Primary outcomes

  1. Fibrin clot polymerisation

    Time frame: At inclusion

    maximal absorption (optical density)

  2. Fibrin clot permeability

    Time frame: At inclusion

    darcy coefficient (ks, cm2)

  3. Fibrinolysis

    Time frame: At inclusion

    Clot lysis time (min)

  4. Thrombin generation

    Time frame: At inclusion

    Endogenous thrombin potential (ETP, nM x min)

  5. Coated platelets

    Time frame: At inclusion

    Absolute number of coated platelets

Secondary outcomes

  1. Fibrinogen gamma' levels

    Time frame: At inclusion

    Ratio fibrinogen gamma'/total fibrinogen (%)

  2. Scan electron microscopy

    Time frame: At inclusion

    Fibrin fiber diameter (nm)

  3. Clot retraction

    Time frame: At inclusion

    Ratio clot weight/serum extruded (%)

  4. Plasmin generation

    Time frame: At inclusion

    Plasmin (nM)

  5. Fibrin clot formation (thrombodynamics)

    Time frame: At inclusion

    Initial rate of clot growth (μM/min)

  6. Major bleeding episodes

    Time frame: Three years

    Incidence of major bleeding

  7. Non-major bleeding episodes

    Time frame: Three years

    Incidence of clinically relevant non-major bleeding

  8. Health related quality of life

    Time frame: three years

    SF36 questionnaire, 0 - 100 (high score, better outcome)

  9. International Society Thrombosis Hemostasis Bleeding assessment tool

    Time frame: three years

    ISTH BAT score, 0 - 56 (high score, worse outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Casini

CONTACT

[email protected]

0041223729757

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

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

Acronym: SWISS-BUC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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