CHU de Saint-Etienne
Saint-Etienne, 42055, France
NCT Number: NCT03801122
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Saint-Etienne, 42055, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of tranexamic acid, with 3 injections/8 hours.
Time frame: 30 days
Amplitude levels observed in thromboelastography will be reported
Time frame: 30 minutes
Time at the beginning of the clot will be reported in minutes
Time frame: 30 minutes
Clot formation time will ne reported in minutes
Time frame: 30 days
Alpha angle will be measured in degrees
Time frame: 30 minutes
Percentage of lysis after 30min will be measured
Time frame: 30 days
Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported
Time frame: 3 months
Number of adverse events will be reported
Centre Hospitalier Universitaire de Saint Etienne
Other
Study of Thromboelastography During Tranexamic Acid Treatment in Preventing Bleeding in Patients With Haematological Malignancies Presenting Severe Thrombocytopenia (TTRAP-bleeding)
Acronym: TTRAP-Bleeding
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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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