ClinicalTrials.gg
RecruitingNCT05713734SWISS-BUCUpdated Apr 29, 2026

Bleeding of Unknown Cause: a Swiss Case-control Study

An observational study in Bleeding Disorder, sponsored by University Hospital, Geneva. Recruiting at 7 sites in Switzerland. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University Hospital, Geneva · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bleeding Disorder

Keywords

  • Bleeding
  • Hemostatics
  • Fibrin
  • Fibrinolysis
  • Thrombin
03

In context

Hemostatic Disorders

361 studies on the registry are indexed under Hemostatic Disorders; 65 are open to participants now.

This study's planned enrollment of 400 is above the median of 120 across 174 observational studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • 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

06

What researchers measure

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

  5. Coated platelets

    Absolute number of coated platelets

    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

  5. Fibrin clot formation (thrombodynamics)

    Initial rate of clot growth (μM/min)

    Time frame: At inclusion

  6. Major bleeding episodes

    Incidence of major bleeding

    Time frame: Three years

  7. Non-major bleeding episodes

    Incidence of clinically relevant non-major bleeding

    Time frame: Three years

  8. Health related quality of life

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

    Time frame: three years

  9. International Society Thrombosis Hemostasis Bleeding assessment tool

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

    Time frame: three years

07

Study locations

7 of 7 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Jun 2026, 38 months after the start.

Of 98 non-industry observational studies under Hemostatic Disorders, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 57. This study's planned 38 months is above that.

Counting every sponsor, half of 108 studies reached it within 24 months; a quarter within 9 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2023
First posted
Feb 6, 2023
StartActual
Apr 1, 2023
Primary completionEst.
Jun 1, 2026
CompletionEst.
Apr 1, 2027
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05713734
Responsible party
Casini Alessandro (Principal investigator, University Hospital, Geneva) — Principal investigator
First posted
Feb 6, 2023
Start date
Apr 1, 2023
Primary completion
Jun 1, 2026 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Apr 29, 2026

Study contacts

Alessandro Casini
Contact
alessandro.casini@hcuge.ch
0041223729757
Alessandro Casini
principal investigator · University Hospitals of Geneva

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion