Evolution of Thromboelastography During Tranexamic Acid Treatment

Hematological Malignancies Treated With Intensive Chemotherapy Clinical Trial

— TTRAP-Bleeding  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801122
• Other study ID #: 2018-1201
• Secondary ID: 2018-004756-38
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2019
• Est. completion date: July 11, 2022

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 11, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies Treated With Intensive Chemotherapy
• Neoplasms

Intervention

Drug:
• Tranexamic acid
Administration of tranexamic acid, with 3 injections/8 hours.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of amplitude observed in thromboelastography	Amplitude levels observed in thromboelastography will be reported	30 days
Secondary	Time at the beginning of the clot	Time at the beginning of the clot will be reported in minutes	30 minutes
Secondary	Clot formation time	Clot formation time will ne reported in minutes	30 minutes
Secondary	Alpha angle	Alpha angle will be measured in degrees	30 days
Secondary	Percentage of lysis after 30min	Percentage of lysis after 30min will be measured	30 minutes
Secondary	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
Secondary	Number of adverse events	Number of adverse events will be reported	3 months