Evolution of Thromboelastography During Tranexamic Acid Treatment (TTRAP-Bleeding)

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

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.

Study Overview

• Status: Completed
• Conditions: Hematological Malignancies Treated With Intensive Chemotherapy
• Intervention / Treatment: Drug: Tranexamic acid

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid 3g/day; Administration of tranexamic acid 3g/day, with 3 injections/8 hours.	Drug: Tranexamic acid; Administration of tranexamic acid, with 3 injections/8 hours.
Experimental: Tranexamic acid 1.5g/day; Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.	Drug: Tranexamic acid; Administration of tranexamic acid, with 3 injections/8 hours.
No Intervention: No treatment; 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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): March 9, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: bleeding; thrombocytopenia; hematological malignancies; Tranexamic acid
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2018-1201; 2018-004756-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No