Hematological Malignancies Treated With Intensive Chemotherapy
Conditions
Keywords
Tranexamic acid, bleeding, hematological malignancies, thrombocytopenia
Brief summary
Patients with hematological malignancies are at increased risk of bleeding, especially during intensive chemotherapy. The aim of this study is to compare by thromboelastography changes during the intensive chemotherapy in patients with hematological malignancies.
Detailed description
Patients with hematological malignancies often develop low platelet counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). The last studies have showed that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is an antifibrinolytic agent. It reduces the breakdown of clots formed. This treatment is widely used in medicine (e.g. emergency, surgery, post-partum) and decreases blood loss and the use of red cell transfusions. The purpose of this study is to test different doses of tranexamic acid (full dose: 3g/day and half dose (1.5g/day) and to study its effect by thromboelastography, with the aim to determine the optimal posology for further clinical studies.
Interventions
DRUGTranexamic acid
Administration of tranexamic acid, with 3 injections/8 hours.
Sponsors
Institut de Cancérologie de la Loire
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient affiliated to a social security regimen or beneficiary of the same * Signed written informed consent form * Confirmed diagnosis of a hematological malignancy and undergoing intensive chemotherapy * Expected to experience hypoproliferative thrombocytopenia resulting in a platelet count of ≤10 G/L for ≥ 5 days
Exclusion criteria
* Pregnant women * Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent * Refractoriness to platelet transfusion or requirement for a specific type of platelet transfusion (ABO-compatible, plasma-free) * Ongoing anticoagulant therapy or antiplatelet therapy at the time of enrolment * Treatment with any pro-coagulant agent within 48 hours of enrolment, or enrolment in other trials involving platelet transfusions, platelet growth factors, or presentation of a known hypercoagulable state * Diagnosis of arterial or venous thromboembolic disease within the previous year * Patient experiencing a bleeding event WHO grade ≥ 2 within 7 days before inclusion * contra-indications to tranexamic acid (allergy, history of seizures, creatinine clearance \< 30 mL/min) * Refusing participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of amplitude observed in thromboelastography | 30 days | Amplitude levels observed in thromboelastography will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clot formation time | 30 minutes | Clot formation time will ne reported in minutes |
| Alpha angle | 30 days | Alpha angle will be measured in degrees |
| Time at the beginning of the clot | 30 minutes | Time at the beginning of the clot will be reported in minutes |
| Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above | 30 days | Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported |
| Number of adverse events | 3 months | Number of adverse events will be reported |
| Percentage of lysis after 30min | 30 minutes | Percentage of lysis after 30min will be measured |
Countries
France
Outcome results
None listed