Predicting bleeding risk in patients with severe thrombocytopenia using a viscoelastic and clinical score

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, non-randomized exploratory study aiming to create and validate the VISCOTHEM score, which blends viscoelastic test parameters with conventional lab and clinical factors to predict immediate bleeding risk in patients with severe thrombocytopenia. The project will use additional blood samples (total ~21 mL) for viscoelastic testing (Quantra, Rotem) alongside standard care, to identify a threshold with negative predictive value ≥95% for zero residual bleeding risk. Enrollment includes adults with malignant hematologic disorders or bone marrow failure, platelet count <20 G/L, and no recent transfusion, regardless of active bleeding status. Exclusion criteria remove patients on recent anticoagulants or antiplatelet therapy that could confound bleeding risk. The study is led by Centre Hospitalier Annecy Genevois at CH Annecy Genevois (Épagny) with no listed collaborators at this time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients;
* Who have been informed about the study and have freely given their informed consent to participate in the study;
* With a malignant haematological disorder or bone marrow failure, whether treated or untreated and at any stage of treatment;
* With central thrombocytopenia strictly below 20 G/L in a blood sample taken less than 72 hours ago and not having received a transfusion since;
* Admitted to a haematology day unit or inpatient ward, or being followed up at a haematology outpatient clinic;
* With or without active bleeding;
* Affiliated with or covered by a social security scheme.

Exclusion Criteria:

* Patients who have received at least one of the following treatments:
* Antiplatelet agents within 7 days prior to enrolment,
* Vitamin K antagonists within 7 days prior to enrolment,
* Direct oral anticoagulants within 72 hours prior to enrolment,
* Low molecular weight heparin within 24 hours prior to inclusion,
* Unfractionated heparin within 6 hours prior to inclusion,
* Bruton's tyrosine kinase inhibitor (ibrutinib, zanubrutinib or acalabrutinib) within 72 hours prior to inclusion;
* Patients with a history of thrombopathy;
* Patients with a history of haemostatic disorders carrying a risk of haemorrhage or thrombosis;
* Thrombocytopenia associated with immune thrombocytopenic purpura or disseminated intravascular coagulation;
* Patients already enrolled in the study;
* Pregnant or breastfeeding women;
* Patients under guardianship or curatorship;
* Patients who do not understand French;
* Patients under judicial protection.

Where it's running

• CH Annecy Genevois
  Épagny, Auvergne-Rhône-Alpes, France Recruiting

Study contacts

• Study coordinator: Marion GHIDI
• Email: mghidi@ch-annecygenevois.fr
• Phone: +33450637031

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.