TTRAP-Bleeding: Evolution of Thromboelastography During Tranexamic Acid Treatment

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT03801122

Collaborator

Institut de Cancérologie de la Loire (Other)

Enrollment

Location

Arms

36.9

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancies Treated With Intensive Chemotherapy	Drug: Tranexamic acid	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acidArm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 5, 2019

Anticipated Primary Completion Date :

Feb 10, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Level of amplitude observed in thromboelastography [30 days]
Amplitude levels observed in thromboelastography will be reported

Secondary Outcome Measures

Time at the beginning of the clot [30 minutes]
Time at the beginning of the clot will be reported in minutes
Clot formation time [30 minutes]
Clot formation time will ne reported in minutes
Alpha angle [30 days]
Alpha angle will be measured in degrees
Percentage of lysis after 30min [30 minutes]
Percentage of lysis after 30min will be measured
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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