Interpretability of the Quantra® Viscoelastic Test in Patients With Haematological Malignancies W… (NCT06455553) | Clinical Trial Compass
CompletedNot Applicable
Interpretability of the Quantra® Viscoelastic Test in Patients With Haematological Malignancies With Profound Thrombocytopenia Below 50x10 G/L.
France48 participantsStarted 2024-06-26
Plain-language summary
The goal of this single-center, non-controlled, non-randomized exploratory clinical trial is to evaluate the interpretability of viscoelastic tests (Quantra® and ROTEM® type) in relation to platelet levels measured in standard biology in patients with haematological malignancies, hospitalized in day hospitals or full hematology wards, presenting thrombocytopenia strictly below 50 G/L.
Participants will undergo an additional blood sample to standard care. The total volume of blood drawn will be 12.1 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient age \> 18 years old ;
* Patients who have been informed of the study and have freely given their informed consent to participate in the study;
* Patients with hematologic malignancies, treated or untreated, at any stage of treatment;
* Patient with thrombocytopenia strictly below 50 G/L on a blood sample taken less than 72 hours ago;
* Patient hospitalized in day hospitalization or in full hematology hospitalization;
* Patient covered by a French social security scheme.
Exclusion Criteria:
* Patients treated with antiplatelet agents or anticoagulants in preventive or curative doses;
* Patient with a history of thrombopathy;
* Patient with a history of haemostasis pathology at risk of haemorrhage or thrombosis;
* Pregnant or breast-feeding patients;
* Patients under guardianship;
* Patients who do not understand French;
* Patients under court protection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the correlation between Quantra® (Clot firmness) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.
Timeframe: At baseline, before platelet transfusion
2
Evaluate the correlation between Quantra® (Platelet contribution to clot) and conventional biology results in patients with hematologic malignancies with platelet counts strictly below 50 G/L.
Timeframe: At baseline, before platelet transfusion