Clinical trial · Interventional
Evolution of Thromboelastography During Tranexamic Acid Treatment
Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)
NCT03801122CI-TRIAL-00066165TTRAP-BleedingcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies Treated With Intensive Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tranexamic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Tranexamic acid 3g/day
- description
- Administration of tranexamic acid 3g/day, with 3 injections/8 hours.
- interventionNames
- Drug: Tranexamic acid
- type
- EXPERIMENTAL
- label
- Tranexamic acid 1.5g/day
- description
- Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours.
- interventionNames
- Drug: Tranexamic acid
- type
- NO_INTERVENTION
- label
- No treatment
- description
- No treatment (no administration of tranexamic acid)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.