Evolution of Thromboelastography During Tranexamic Acid Treatment

NCT ID: NCT03801122

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2022-07-11

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.

Conditions

Hematological Malignancies Treated With Intensive Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic acid 3g/day

Administration of tranexamic acid 3g/day, with 3 injections/8 hours.

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

Administration of tranexamic acid, with 3 injections/8 hours.

Tranexamic acid 1.5g/day

Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

Administration of tranexamic acid, with 3 injections/8 hours.

No treatment

No treatment (no administration of tranexamic acid)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tranexamic acid

Administration of tranexamic acid, with 3 injections/8 hours.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emilie Chalayer, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2018-004756-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2018-1201

Identifier Type: -

Identifier Source: org_study_id