search
Back to results

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
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
December 20, 2018
Last Updated
May 4, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Institut de Cancérologie de la Loire
search

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

We'll reach out to this number within 24 hrs