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Trial record 79 of 419 for:    TRANEXAMIC ACID

Evolution of Thromboelastography During Tranexamic Acid Treatment (TTRAP-Bleeding)

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ClinicalTrials.gov Identifier: NCT03801122
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : March 5, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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)



Primary Outcome Measures :
  1. Level of amplitude observed in thromboelastography [ Time Frame: 30 days ]
    Amplitude levels observed in thromboelastography will be reported


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801122


Contacts
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Contact: Emilie Chalayer, MD 0477917089 ext +33 emilie.chalayer@icloire.fr
Contact: Elisabeth Daguenet, PhD 0477917089 ext +33 elisabeth.daguenet@icloire.fr

Locations
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France
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Emilie Chalayer, MD    0477917089 ext +33    emilie.chalayer@icloire.fr   
Principal Investigator: Emilie Chalayer, MD         
Sub-Investigator: Jérôme Cornillon, MD         
Sub-Investigator: Denis Guyotat, MD         
Sub-Investigator: Emmanuelle Tavernier, MD         
Sub-Investigator: Caroline Lejeune, MD         
Sub-Investigator: Fressia Honeyman, MD         
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Emilie Chalayer, MD Institut de Cancérologie Lucien Neuwirth

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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03801122     History of Changes
Other Study ID Numbers: 2018-1201
2018-004756-38 ( EudraCT Number )
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de la Loire:
Tranexamic acid
bleeding
hematological malignancies
thrombocytopenia
Additional relevant MeSH terms:
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Neoplasms
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants