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Completed

NCT Number: NCT03801122

Evolution of Thromboelastography During Tranexamic Acid Treatment

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

Administration of tranexamic acid, with 3 injections/8 hours.

Primary outcomes

  1. Level of amplitude observed in thromboelastography

    Time frame: 30 days

    Amplitude levels observed in thromboelastography will be reported

Secondary outcomes

  1. Time at the beginning of the clot

    Time frame: 30 minutes

    Time at the beginning of the clot will be reported in minutes

  2. Clot formation time

    Time frame: 30 minutes

    Clot formation time will ne reported in minutes

  3. Alpha angle

    Time frame: 30 days

    Alpha angle will be measured in degrees

  4. Percentage of lysis after 30min

    Time frame: 30 minutes

    Percentage of lysis after 30min will be measured

  5. Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above

    Time frame: 30 days

    Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported

  6. Number of adverse events

    Time frame: 3 months

    Number of adverse events will be reported

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Institut de Cancérologie de la Loire

Registry information

Official study title

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

Acronym: TTRAP-Bleeding

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2019
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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