Chemotherapy-induced thrombocytopenia in children with solid tumors
Conditions
Interventions
Prevention group:For patients having the risk factors of CIT or level 3 and above CIT in the last chemotherapy cycle, the oral administration of hetrombopag was started 24 h after the end of antineopl
Treatment group:For patients’s platelet count less than 75×109/L after this chemotherapy, the oral administration of hetrombopag was started 24 h after the end of antineoplastic therapy in this cycle.
Control group:no intervention
Sponsors
West China Second University Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: To be enrolled in the study, subjects had to meet all of the following eligibility criteria: To be enrolled in the study, subjects had to meet all of the following eligibility criteria: 1. Histologically or cytologically confirmed solid tumor,Receiving chemotherapy;2. 3=age 3 months.
Exclusion criteria
Exclusion criteria: Patients with any of the following were not eligible for the study: 1.Patients with organ dysfunction, such as severe heart, liver and kidney dysfunction, etc. Severe cardiovascular disease was included, such as myocardial ischemia or grade II myocardial infarction, malignant arrhythmia, Grade III to IV cardiac dysfunction, or left ventricular ejection fraction (LVEF) < 50% on color Doppler echocardiography; Liver failure, renal failure and severe malnutrition were also included. 2. No thrombocytopenia occurs before or after the chemotherapy; 3. Other causes of thrombocytopenia, especially the underlying diseases and complications, such as aplastic anemia, acute leukemia, immune thrombocytopenia, tumor bone marrow invasion and hypersplenism; 4. Ethylenediamine tetraacetic acid (ethylenediaminetetraacetic acid, EDTA) as a test sample of pseudo thrombocytopenia caused by anticoagulant;5. Thrombocytopenia caused by non-chemotherapy factors;6. Patients with grade 4 bleeding;7. Patients who are allergic to any component of hatrombopag ethanolamine; 8. Patients with arteriovenous thrombosis; 9. Patients with active chronic hepatitis B, hepatitis C virus infection, active bacterial infection or fungal infection; 10. Patients who do not take drugs as prescribed in the treatment regimen; 11. Lack of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall reaction score;Duration of grade 3/4 thrombocytopenia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events;Changes in platelet count during treatmentent;Platelet transfusion status;Proportion of subjects with bleeding events ; | — |
Countries
China
Contacts
Public ContactGuo Xia
West China Second University Hospital, Sichuan University
Outcome results
None listed