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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

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE January 11, 2019
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE March 5, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Level of amplitude observed in thromboelastography [ Time Frame: 30 days ]
Amplitude levels observed in thromboelastography will be reported
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03801122 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • Time at the beginning of the clot [ Time Frame: 30 minutes ]
    Time at the beginning of the clot will be reported in minutes
  • Clot formation time [ Time Frame: 30 minutes ]
    Clot formation time will ne reported in minutes
  • Alpha angle [ Time Frame: 30 days ]
    Alpha angle will be measured in degrees
  • Percentage of lysis after 30min [ Time Frame: 30 minutes ]
    Percentage of lysis after 30min will be measured
  • 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
  • Number of adverse events [ Time Frame: 3 months ]
    Number of adverse events will be reported
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evolution of Thromboelastography During Tranexamic Acid Treatment
Official Title  ICMJE Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Hematological Malignancies Treated With Intensive Chemotherapy
Intervention  ICMJE Drug: Tranexamic acid
Administration of tranexamic acid, with 3 injections/8 hours.
Study Arms  ICMJE
  • Experimental: Tranexamic acid 3g/day
    Administration of tranexamic acid 3g/day, with 3 injections/8 hours.
    Intervention: Drug: Tranexamic acid
  • Experimental: Tranexamic acid 1.5g/day
    Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.
    Intervention: Drug: Tranexamic acid
  • No Intervention: No treatment
    No treatment (no administration of tranexamic acid)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emilie Chalayer, MD 0477917089 ext +33 emilie.chalayer@icloire.fr
Contact: Elisabeth Daguenet, PhD 0477917089 ext +33 elisabeth.daguenet@icloire.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03801122
Other Study ID Numbers  ICMJE 2018-1201
2018-004756-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut de Cancérologie de la Loire
Study Sponsor  ICMJE Institut de Cancérologie de la Loire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emilie Chalayer, MD Institut de Cancérologie Lucien Neuwirth
PRS Account Institut de Cancérologie de la Loire
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP