ThrombocytopeniaVISCOTHEM-2NCT07653672
Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia
An observational study of Thrombocytopenia and Platelet Transfusion, run by Centre Hospitalier Annecy Genevois at 1 site in France.
Trial summary
The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia, Platelet Transfusion, Haemorrhage
- What is being tested?
- Additional blood sample
- How many people
- 410 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2026to 15 Jul 2028
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients included will be selected from the entire cohort of patients with haematological malignancies: * those admitted to the haematology day unit for treatment or assessment, * or patients admitted to the haematology inpatient ward, * or patients being monitored in the haematology outpatient clinic.
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CH Annecy Genevois
Épagny, Auvergne-Rhône-Alpes, 74370
Adrien CONTEJEAN, Doctor, +33450636369, acontejean@ch-annecygenevois.fr
About this study
The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate risk of bleeding in haematology patients with severe thrombocytopenia (<20 G/L); with a view to selecting a population with a residual risk of bleeding of zero (NPV ≥ 95%, to achieve a residual probability of bleeding < 5%).
The score may incorporate variables identified in the literature as having a plausible causal relationship with the occurrence of bleeding (14,15), as well as viscoelastometric tests parameters, conventional haemostasis parameters and relevant clinical parameters. .
Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 21.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, urea, creatinin, albumin.
- Being tested
- Additional blood sample
- Keywords
- viscoelasticity test, thrombocytopenia, haematologic disease, risk of bleeding, clinical and laboratory score
- Medical subject headings
- Thrombocytopenia, Hemorrhage, Hematologic Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood sampleBiological
A blood sample will be taken from all patients included in the study. This blood sampling is an added act of the study. It will be performed as soon as possible after inclusion in the study. The total volume of blood drawn will be 21.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, Urea, Creatinine, Albumin.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (additional blood sample) | Intervention (additional blood sample) Receives: Biological: Additional blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of factors associated with bleeding among clinical and laboratory parameters
Clinical parameters : Age, Sex, BMI, systolic and diastolic blood pressure, presence of mucositis, presence of a lesion with haemorrhagic potential, bleeding within the previous 5 days, fever associated with an infection or an episode of febrile neutropenia, transplant within the previous 100 days Laboratory parameters : viscoelastic test parameters, white blood cell count, Haemoglobin, Platelet and immature platelet counts, Urea, Creatinine, Albumin, Standard haemostasis (APTT, INR, Fibrinogen)
Measured: At baseline, before platelet transfusion
Apply a multivariate regression model to develop the VISCOTHEM score for predicting immediate bleeding (WHO score ≥ 1), based on the coefficients of the factors associated with bleeding
Measured: At baseline, before platelet transfusion
Secondary outcomes (4)
Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®.
To propose a score capable of processing a viscoelastic test result from either ROTEM® or Quantra®,
Measured: At baseline, before platelet transfusion
Describe the presence of bleeding according to the WHO classification (WHO score ≥1) and WHO bleeding grade, where applicable
Measured: 72 hours after blood sample
Describe the presence of platelet transfusion
Measured: 72 hours after blood sample
Describe the Vital status or loss of follow-up, where applicable
Measured: 72 hours after blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start18 Sep 2026
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 410 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653672
- Sponsor's protocol ID
- 24-10
- Other IDs
- 2026-A00535-46
- Acronym
- VISCOTHEM-2
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07653672
- Acronym / sponsor ID
- VISCOTHEM-2 / 24-10
- Keywords
- viscoelasticity test, thrombocytopenia, haematologic disease, risk of bleeding, clinical and laboratory score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Jul 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is To develop and validate a clinical-biological score (VISCOTHEM score) incorporating viscoelastometric tests parameters; based on an association study, and to establish a threshold that enables the prediction of the immediate risk of bleeding in haematology patients with severe thrombocytopenia (<20 G/L); with a view to selecting a population with a residual risk of bleeding of zero (NPV ≥ 95%, to achieve a residual probability of bleeding < 5%).
The score may incorporate variables identified in the literature as having a plausible causal relationship with the occurrence of bleeding (14,15), as well as viscoelastometric tests parameters, conventional haemostasis parameters and relevant clinical parameters. .
Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 21.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, urea, creatinin, albumin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention (additional blood sample) | – | Biological: Additional blood sampleIntervention (additional blood sample) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included will be selected from the entire cohort of patients with haematological malignancies: * those admitted to the haematology day unit for treatment or assessment, * or patients admitted to the haematology inpatient ward, * or patients being monitored in the haematology outpatient clinic.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional blood sampleA blood sample will be taken from all patients included in the study. This blood sampling is an added act of the study. It will be performed as soon as possible after inclusion in the study. The total volume of blood drawn will be 21.1 mL. The following analyses will be performed: Quantra®, Rotem®, blood count, platelets, immature platelet count, plasma prothrombin time, activated partial thromboplastin time, International Normalized Ratio, fibrinogen, Urea, Creatinine, Albumin. | Biological | Intervention (additional blood sample) |
Primary outcome
Identification of factors associated with bleeding among clinical and laboratory parameters
Time frame: At baseline, before platelet transfusion
Clinical parameters : Age, Sex, BMI, systolic and diastolic blood pressure, presence of mucositis, presence of a lesion with haemorrhagic potential, bleeding within the previous 5 days, fever associated with an infection or an episode of febrile neutropenia, transplant within the previous 100 days Laboratory parameters : viscoelastic test parameters, white blood cell count, Haemoglobin, Platelet and immature platelet counts, Urea, Creatinine, Albumin, Standard haemostasis (APTT, INR, Fibrinogen)
Apply a multivariate regression model to develop the VISCOTHEM score for predicting immediate bleeding (WHO score ≥ 1), based on the coefficients of the factors associated with bleeding
Time frame: At baseline, before platelet transfusion
4 secondary outcomes
Stratification and comparison of performance and score calibration depending on whether the viscoelastic test result is obtained using ROTEM® or Quantra®.
Time frame: At baseline, before platelet transfusion
Describe the presence of bleeding according to the WHO classification (WHO score ≥1) and WHO bleeding grade, where applicable
Time frame: 72 hours after blood sample
Describe the presence of platelet transfusion
Time frame: 72 hours after blood sample
Describe the Vital status or loss of follow-up, where applicable
Time frame: 72 hours after blood sample
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Thrombocytopenia
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruitingPhase 2
Time-limited Treatment With Avatrombopag Pre- and Post-CAR T-cell Therapy to Prevent Post-CAR T-cell Cytopenias
Thrombocytopenia
RecruitingPhase 2
AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion
Acute Leukemia, Severe Aplastic Anemia
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia and Platelet Transfusion, run by Centre Hospitalier Annecy Genevois at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion GHIDI (+33450637031, mghidi@ch-annecygenevois.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of factors associated with bleeding among clinical and laboratory parameters (time frame: At baseline, before platelet transfusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.