Clinical trial NCT03801122: Evolution of Thromboelastography During Tranexamic Acid Treatment
Official title: Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematological Malignancies Treated With Intensive Chemotherapy
Keywords: Tranexamic acid
bleeding
hematological malignancies
thrombocytopenia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Institut de Cancérologie de la Loire
First posted: 2019-01-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of amplitude observed in thromboelastography
timeFrame: 30 days
Secondary outcomes:
measure: Time at the beginning of the clot
timeFrame: 30 minutes
measure: Clot formation time
timeFrame: 30 minutes
measure: Alpha angle
timeFrame: 30 days
measure: Percentage of lysis after 30min
timeFrame: 30 minutes
measure: Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above
timeFrame: 30 days
measure: Number of adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Emilie Chalayer, MD
role: PRINCIPAL_INVESTIGATOR
References: