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Bleeding of Unknown Cause: a Swiss Case-control Study

ConditionBleeding Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-65
SponsorUniversity Hospital, Geneva

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Patients4 interventions
Group B: Controls4 interventions

Trial outcomes

Primary outcomes

1

Fibrin clot polymerisation

maximal absorption (optical density)

Time frame
At inclusion
2

Fibrin clot permeability

darcy coefficient (ks, cm2)

Time frame
At inclusion
3

Fibrinolysis

Clot lysis time (min)

Time frame
At inclusion
4

Thrombin generation

Endogenous thrombin potential (ETP, nM x min)

Time frame
At inclusion

Secondary outcomes

1

Fibrinogen gamma' levels

Ratio fibrinogen gamma'/total fibrinogen (%)

Time frame
At inclusion
2

Scan electron microscopy

Fibrin fiber diameter (nm)

Time frame
At inclusion
3

Clot retraction

Ratio clot weight/serum extruded (%)

Time frame
At inclusion
4

Plasmin generation

Plasmin (nM)

Time frame
At inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Geneva

Lead sponsor

Source ClinicalTrials.gov
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