Thrombocytopenia associated with treatment of hematologic malignancies
Conditions
Interventions
Eltrombopag intervention group:Eltrombopag 75mg qd po for up to 2 weeks
rVIIa intervention group:rVIIa 70-90ug/kg once
no more than 3 times
Eltrombopag control group:Not suitable for platelet active drugs, such as IL-11, tpo-ra, TPO, etc
rVIIa control group:Non rVIIa related treatment hemostasis measures
Sponsors
Xuancheng people's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The treatment group and the control group were treated with Eltrombopag: 1. 80 years old >= 18 years old, regardless of gender. 2. The patients were clinically diagnosed with hematologic malignancies (AML, all, NHL, HL, mm, etc.); 3. Received at least one chemotherapy or radiotherapy; 4. Treatment related myelosuppression occurred (PLT= 18 years old, regardless of gender. 2. The patients were clinically diagnosed with hematologic malignancies (AML, all, NHL, HL, mm, etc.); 3. Received at least one chemotherapy or radiotherapy; 4. Treatment related myelosuppression occurred (PLT= 3 months. 8. WHO grade >= 2 bleeding occurred during myelosuppression.
Exclusion criteria
Exclusion criteria: The treatment group and the control group were treated with Eltrombopag: 1. previous TPO-RA resistance or intolerance, allergy, etc; 2. The presence of bleeding or other non malignant hematological diseases and non hematological tumor diseases that cause thrombocytopenia; 3. Active thrombotic events (DVT, PE, cerebral infarction, myocardial infarction within 6 months); 4. Hereditary hemorrhagic disease or combined use of dual antibody / warfarin can not be discontinued; 5. Uncontrolled hypertension (SBP >= 160mmhg or DBP >= 100 mmHg) or pregnancy, lactation or planned pregnancy within 3 months; 6. Concurrent chemoradiotherapy is necessary for patients with other malignant tumors; 7. HIV active infection or active HBV (HBV-DNA >= 2000 iu/ml); 8. Patients with uncontrolled mental or epileptic diseases were included; 9. Other conditions that the investigator judged were not suitable for enrollment: such as combined coagulation disorders, hemophilia, rodenticide poisoning, lack of coagulation factors, etc; 10. At the same time, use other thrombopoiesis promoting drugs (such as interleukin-11, TPO, etc.); 11. Patients with serious lack of clinical data. In the rVIIa treatment group and the control group: 1. known allergy to rFVIIa; 2. The presence of bleeding or other non malignant hematological diseases and non hematological tumor diseases that cause thrombocytopenia; 3. Active thrombotic events (DVT, PE, cerebral infarction, myocardial infarction within 6 months); 4. Hereditary hemorrhagic disease or combined use of dual antibody / warfarin can not be discontinued; 5. Uncontrolled hypertension (SBP >= 160mmhg or DBP >= 100 mmHg) or pregnancy, lactation or planned pregnancy within 3 months; 6. Concurrent chemoradiotherapy is necessary for patients with other malignant tumors; 7. HIV active infection or active HBV (HBV-DNA >= 2000 iu/ml); 8. Patients with uncontrolled mental or epileptic diseases were included; 9. Other conditions that the investigator judged were not suitable for enrollment: such as combined coagulation disorders, hemophilia, rodenticide poisoning, lack of coagulation factors, etc; 10. Patients with serious lack of clinical data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| platelet count;Platelet count recovery time (without platelet transfusion);Hemostasis rate at 24 hours , 48 hours and 72 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Thrombotic events;Changes in coagulation function;Blood product infusion;Time of platelet lower than 20×10^9/L;Incidence of bleeding events (including the incidence of bleeding above who grade 2);rVIIa usage and frequency;Duration and total amount of eltrombopag;Cost effectiveness Statistics (QALY); | — |
Countries
China
Contacts
Public ContactJun Lu
hospital of xuancheng people
Outcome results
None listed