Evolution of Thromboelastography During Tranexamic Acid Treatment

Study Overview
=================
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.

Official Title
-----------------
Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)

Conditions
-----------------
Hematological Malignancies Treated With Intensive Chemotherapy

Intervention / Treatment
-----------------
* Drug: Tranexamic acid


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid 3g/day<br>Administration of tranexamic acid 3g/day, with 3 injections/8 hours. | Drug: Tranexamic acid<br>* Administration of tranexamic acid, with 3 injections/8 hours.<br>|
| Experimental: Tranexamic acid 1.5g/day<br>Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours. | Drug: Tranexamic acid<br>* Administration of tranexamic acid, with 3 injections/8 hours.<br>|
| No Intervention: No treatment<br>No treatment (no administration of tranexamic acid) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of amplitude observed in thromboelastography | Amplitude levels observed in thromboelastography will be reported | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at the beginning of the clot | Time at the beginning of the clot will be reported in minutes | 30 minutes | 
| Clot formation time | Clot formation time will ne reported in minutes | 30 minutes | 
| Alpha angle | Alpha angle will be measured in degrees | 30 days | 
| Percentage of lysis after 30min | Percentage of lysis after 30min will be measured | 30 minutes | 
| Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above | Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported | 30 days | 
| Number of adverse events | Number of adverse events will be reported | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tranexamic acid, bleeding, hematological malignancies, thrombocytopenia