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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004756-38 | EudraCT Number |
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| Name | Class |
|---|---|
| Institut de Cancérologie de la Loire | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid 3g/day | Experimental | Administration of tranexamic acid 3g/day, with 3 injections/8 hours. |
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| Tranexamic acid 1.5g/day | Experimental | Administration of tranexamic acid 1.5g/day, with 3 injections/8 hours. |
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| No treatment | No Intervention | No treatment (no administration of tranexamic acid) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Administration of tranexamic acid, with 3 injections/8 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Level of amplitude observed in thromboelastography | Amplitude levels observed in thromboelastography will be reported | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time at the beginning of the clot | Time at the beginning of the clot will be reported in minutes | 30 minutes |
| Clot formation time | Clot formation time will ne reported in minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Chalayer, MD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D019337 | Hematologic Neoplasms |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Arm 1 : Tranexamic acid 3g/day Arm 2 : Tranexamic acid 1.5g/day Arm 3 : No tranexamic acid
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| 30 minutes |
| Alpha angle | Alpha angle will be measured in degrees | 30 days |
| Percentage of lysis after 30min | Percentage of lysis after 30min will be measured | 30 minutes |
| Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above | Proportion of patients experiencing bleeding of WHO (World Health Organisation ) grade 2 or above will be reported | 30 days |
| Number of adverse events | Number of adverse events will be reported | 3 months |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |