Thrombocytopenia/aplastic anemia due to chemotherapy for acute leukemia
Conditions
Interventions
Test group 1:Intravenous infusion 1×10^11 platelets
Test group 2:Intravenous infusion 2×10^11 platelets
Sponsors
Bengbu Third People's Hospital
Eligibility
Sex/Gender
All
Age
10 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1. Age 10 or older, male or female; 2. histopathological or cytological examination confirmed acute leukemia (except induction therapy, acute promyelocytic leukemia), is receiving chemotherapy treatment; Or a patient with aplastic anemia clearly diagnosed by a clinician through bone penetration; 3. 10×10^9/L<= PLT <=30×10^9/L (Platelet values need to be reviewed at D-1 during the screening period, and can be included in the group if meeting the criteria); 4. No peripheral blood platelet infusion was received three days before receiving human platelets; 5. ECOG score <=2; 6. The subject or (and) his guardian (if any) understands and signs the informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be admitted to the study: 1. There is a history of ineffective platelet transfusion (ineffective platelet transfusion: the patient is still in an unresponsive state after receiving two consecutive platelet transfusions of sufficient dose, that is, the clinical bleeding performance has not improved; Platelet count did not increase significantly, but sometimes decreased. The injected platelets have a short life span in vivo; CCI and PPR fail to reach the standard for 20-24 h CCI=2000IU/mL in the last 3 months; 16. Uncontrolled active infected persons; 17. Weight greater than 80kg; 18. Have received hematopoietic stem cell transplantation and have acute graft-versus-host disease that needs to be controlled; Anti-human thymocyte immunoglobulin (ATG) during and 1 week after application; Or patients with obvious serological reaction; 19. Women of childbearing age are pregnant or breastfeeding, and male subjects plan to donate sperm within 180 days after administration of the drug; 20. The investigator considers that due to any medical condition, the assessment is unable to participate in the study, or follow-up studies cannot be completed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine;blood biochemical;blood clotting;PK detection (platelet count detection);hrombelastogram;Hemostatic function (PFA-200);Vital sign;Bleeding condition;New tumor incidence;PFA-200; | — |
Secondary
| Measure | Time frame |
|---|---|
| CCI;Exploratory biomarkers;urinalysis;ADA ;Nab; | — |
Countries
China
Contacts
Public ContactLiu Guiling/Zhou Huan
Bengbu Third People's Hospital
Outcome results
None listed