Evolution of Thromboelastography During Tranexamic Acid Treatment (TTRAP-Bleeding)
Primary Purpose
Hematological Malignancies Treated With Intensive Chemotherapy
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancies Treated With Intensive Chemotherapy focused on measuring Tranexamic acid, bleeding, hematological malignancies, thrombocytopenia
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
Sites / Locations
- CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Tranexamic acid 3g/day
Tranexamic acid 1.5g/day
No treatment
Arm Description
Administration of tranexamic acid 3g/day, with 3 injections/8 hours.
Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.
No treatment (no administration of tranexamic acid)
Outcomes
Primary Outcome Measures
Level of amplitude observed in thromboelastography
Amplitude levels observed in thromboelastography will be reported
Secondary Outcome Measures
Time at the beginning of the clot
Time at the beginning of the clot will be reported in minutes
Clot formation time
Clot formation time will ne reported in minutes
Alpha angle
Alpha angle will be measured in degrees
Percentage of lysis after 30min
Percentage of lysis after 30min will be measured
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
Number of adverse events
Number of adverse events will be reported
Full Information
NCT ID
NCT03801122
First Posted
December 20, 2018
Last Updated
May 4, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Institut de Cancérologie de la Loire
1. Study Identification
Unique Protocol Identification Number
NCT03801122
Brief Title
Evolution of Thromboelastography During Tranexamic Acid Treatment
Acronym
TTRAP-Bleeding
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
March 9, 2022 (Actual)
Study Completion Date
July 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Institut de Cancérologie de la Loire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies Treated With Intensive Chemotherapy
Keywords
Tranexamic acid, bleeding, hematological malignancies, thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tranexamic acid 3g/day
Arm Type
Experimental
Arm Description
Administration of tranexamic acid 3g/day, with 3 injections/8 hours.
Arm Title
Tranexamic acid 1.5g/day
Arm Type
Experimental
Arm Description
Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment (no administration of tranexamic acid)
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Administration of tranexamic acid, with 3 injections/8 hours.
Primary Outcome Measure Information:
Title
Level of amplitude observed in thromboelastography
Description
Amplitude levels observed in thromboelastography will be reported
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time at the beginning of the clot
Description
Time at the beginning of the clot will be reported in minutes
Time Frame
30 minutes
Title
Clot formation time
Description
Clot formation time will ne reported in minutes
Time Frame
30 minutes
Title
Alpha angle
Description
Alpha angle will be measured in degrees
Time Frame
30 days
Title
Percentage of lysis after 30min
Description
Percentage of lysis after 30min will be measured
Time Frame
30 minutes
Title
Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above
Description
Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported
Time Frame
30 days
Title
Number of adverse events
Description
Number of adverse events will be reported
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Chalayer, MD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evolution of Thromboelastography During Tranexamic Acid Treatment
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